$Becton Dickinson BD Plastipak Tuberculin Syringe 1ml with 27G x 3/8\ Needle (Box of 120)$

Becton Dickinson BD Plastipak Tuberculin Syringe 1ml with 27G x 3/8\ Needle (Box of 120)

Becton Dickinson

Medical device

Tuberculin syringe with attached hypodermic needle

CE Marked medical device under EU Medical Devices Directive 93/42/EEC (and subsequent amendments) as a Class I sterile device with measuring function (1–10 ml syringes).
Manufactured under ISO 13485 Certified quality management systems at BD medical device manufacturing sites.
Complies with EN ISO 7886 1 for sterile hypodermic syringes for single use (manual use).
Complies with ISO 594 / EN 1707 requirements for Luer conical fittings used on syringes and needles.
Sterilised according to EN ISO 11135 1 for ethylene oxide sterilisation of health Care products, with validated processes.
Biocompatibility evaluated in accordance with ISO 10993 1 and related parts for medical devices in contact with bodily tissues and fluids.
Latex Free, PVC Free and DEHP Free, with no identified REACH Substances of Very High Concern (SVHC) above 0.1% w/w for referenced product numbers.

CE Marked medical device under EU Medical Devices Directive 93/42/EEC (and subsequent amendments) as a Class I sterile device with measuring function (1–10 ml syringes).
Manufactured under ISO 13485 Certified quality management systems at BD medical device manufacturing sites.
Complies with EN ISO 7886 1 for sterile hypodermic syringes for single use (manual use).
Complies with ISO 594 / EN 1707 requirements for Luer conical fittings used on syringes and needles.
Sterilised according to EN ISO 11135 1 for ethylene oxide sterilisation of health Care products, with validated processes.
Biocompatibility evaluated in accordance with ISO 10993 1 and related parts for medical devices in contact with bodily tissues and fluids.
Latex Free, PVC Free and DEHP Free, with no identified REACH Substances of Very High Concern (SVHC) above 0.1% w/w for referenced product numbers.

Tuberculin syringe with attached hypodermic needle

Description

The BD Plastipak Tuberculin Syringe 1ml with attached 27G x 3/8\ needle is a low-dose, small-volume hypodermic syringe designed for intradermal and subcutaneous administration of very small quantities of medication, such as those used in tuberculin (TB) testing, allergy testing and other diagnostic or therapeutic procedures. It features a 1ml clear barrel with fine 0.01ml graduations for precise dosing, a Luer slip nozzle with permanently mounted 27G intradermal bevel needle, and a smooth-gliding polypropylene plunger. The syringe is sterile, single use, latex-free, PVC-free and DEHP-free, supplied individually blister packed, with 120 syringes per box.

Bnefits

Fine 0.01 ml graduations on a clear 1 ml barrel for accurate measurement of very small doses required in tuberculin and allergy testing.
Preassembled with a 27 G x 3/8" intradermal bevel needle to support precise intradermal injection technique.
Luer slip nozzle and permanently attached needle help minimise dead space and reduce the risk of needle detachment.
Three-part syringe design (barrel, plunger and elastomer stopper) provides smooth plunger movement and controlled injection.
Manufactured from latex-free and PVC-free materials, reducing the risk of latex or PVC-related reactions.
Sterile and single use, helping to reduce the risk of cross-contamination and infection.
Ethylene oxide (EO) sterilised with validated process and 5-year shelf life when stored as recommended.
Lightweight and easy to handle, suitable for use in a wide range of clinical settings including hospitals, GP practices and diagnostic centres.
Consistent BD quality and compatibility with standard injection techniques and protocols worldwide.

Indications

Administration of small-volume intradermal injections such as tuberculin (Mantoux) skin tests.
Allergy testing and other intradermal diagnostic procedures requiring volumes up to 1 ml.
Subcutaneous or other low-dose injections where a fine 27 G needle and 1 ml syringe are clinically appropriate.
General purpose injection and aspiration of fluids below the surface of the skin in volumes up to 1 ml, according to institutional protocols.
Use by trained healthcare professionals in hospitals, clinics, physician offices, occupational health, public health and similar settings.

Composition

Syringe barrel: medical-grade polypropylene (PP), clear.
Plunger rod: medical-grade polypropylene (PP).
Plunger stopper: latex-free elastomer (synthetic rubber).
Needle tubing: stainless steel, 27 G x 3/8" intradermal bevel.
Lubricant on barrel interior: medical-grade silicone oil (<0.25 mg/cm²).
Primary unit packaging: polyamide/polyethylene (blister web) and medical-grade paper.
Shelf box: hard paper/cardboard.
Latex free, PVC free, DEHP free and free from Bisphenol A in standard configurations.

Formulation

Device type: 3-piece hypodermic tuberculin syringe with attached needle.
Capacity: 1 ml nominal volume.
Graduation scale: 0.01 ml increments for fine dosing.
Tip: Luer slip concentric nozzle.
Needle: 27 G x 3/8" (approx. 0.4 mm x 10 mm) intradermal bevel, permanently attached.
Construction: barrel and plunger in polypropylene with latex-free elastomer stopper.
Sterilisation: ethylene oxide (EO) sterilised according to EN ISO 11135-1; ETO residues within applicable limits.
Shelf life: typically 5 years from date of manufacture when stored as recommended.
Design: sterile, single-use, disposable device for manual injection.

Packaging

Each syringe is individually packed in a sterile blister (unit pack).
Box (shelf pack) contains 120 individually packed 1 ml BD Plastipak tuberculin syringes with attached 27 G x 3/8" needle.
Shipping case typically contains 960 syringes (8 boxes of 120), depending on distributor configuration.
Outer packaging is labelled with product description, volume, gauge and length, lot number and expiry date, along with standard medical device symbols.

Usage

For use only by trained healthcare professionals familiar with intradermal and subcutaneous injection techniques.
Before use, check the integrity of the sterile blister pack; do not use if packaging is open, damaged or past the expiry date.
Open the blister aseptically and remove the syringe, taking care not to touch the needle.
Draw up the required volume of medication using aseptic technique, ensuring air bubbles are minimised and dosage is set precisely using the 0.01 ml scale.
For intradermal injections (e.g. tuberculin test), insert the 27 G x 3/8" needle bevel up at a shallow angle into the dermis and inject slowly according to local protocols.
Do not attempt to detach, bend or re-use the needle; the syringe and needle are designed for single use only.
After injection, activate any local sharps safety procedures, avoid recapping and dispose of the used syringe immediately in an approved sharps container.
Follow institutional policies and national guidelines for tuberculin testing, allergy testing and other uses of intradermal syringes.

Contraindications

Do not use in patients with known hypersensitivity to any component that may contact the patient (for example, sensitivity to silicone oil or stainless steel) where clinically relevant.
Do not use if the sterile barrier is damaged, compromised or the product is past its expiry date.
Do not use for infusion via power-driven syringe pumps or for purposes other than those specified for hypodermic injection and aspiration.
Do not exceed the 1 ml nominal volume or force the plunger beyond the end of the graduation scale.
Not intended for reprocessing, resterilisation or reuse.

Adverse Effects

Local pain, redness, swelling or minor bleeding at the injection site, as can occur with any needle injection.
Potential for infection or abscess at the injection site if aseptic technique is not strictly followed.
Risk of needlestick injury to healthcare workers if sharps safety protocols are not followed.
Allergic or hypersensitivity reactions related to the administered medication or, rarely, to device materials.
Tissue damage or incorrect administration (for example, too deep or too superficial) if injection technique is inappropriate.

Storage Conditions

Store in a dry, clean environment at normal room temperature.
Keep away from direct sunlight, strong light sources and excessive heat or humidity.
Do not freeze or expose packaging to conditions that could compromise sterility.
Keep in original packaging until point of use to maintain sterility and protect from contamination.
Observe the expiry date on the box and unit packs; do not use after this date.

Duration

Not applicable to the device itself; the syringe is used for single, short procedures. Duration and course of treatment depend on the medication or diagnostic test protocol rather than the syringe.

Onset

Not applicable to the syringe; onset and duration of clinical effect are determined by the drug or diagnostic agent administered and the injection technique used.