Sex: M
Vaccine: HIBV
Symptoms: Immediate post-injection reaction, Injury associated with device, Needle issue, Product complaint, Product leakage
Clinical narrative: needle remained stuck in the infant's thigh; underdose; needle remained stuck in the infant's thigh and some medication leaked; accidental exposure; Cannot attach needle to syringe/needle did not fully lock; Product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a infant male patient who received Hib (Hiberix) (batch number 7ac3c, expiry date 30-SEP-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, immediately after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: needle remained stuck in the infant's thigh), accidental underdose (Verbatim: underdose), exposure via skin contact (Verbatim: needle remained stuck in the infant's thigh and some medication leaked), inadvertent exposure to vaccine (Verbatim: accidental exposure), syringe connection issue (Verbatim: Cannot attach needle to syringe/needle did not fully lock) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the accidental needle stick was not reported and the outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine, syringe connection issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.     It was unknown if the company considered the accidental needle stick to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-APR-2024 The registered nurse stated that in a box of Hiberix the 1 dose had plunger issues and 3 doses had issues with the needle not properly attaching to the syringe. During administration the defect was discovered with one dose with the needle issue that after the medication was pushed through, the needle remained stuck in the infant's thigh and some medication leaked, which led to accidental needle stick, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The registered nurse discarded suspect products and would return needle and remaining doses in the box (5 or 6) because she did not feel comfortable using the remaining doses. The nurse did not requested replacements at this time.  The nurse reported that both the part rod and stopper of plunger were loose and fell out completely while trying to withdraw reconstituted medication from vial. The detachment did not happen during use were liquid and/or dried liquid traces found in the blister. The luer lock needle was used, needle did not fully lock. The nurse used hypodermic needle Pro Edge 25g multiply by 5/8 in used for administering and 25g multiply by 1 in for preparing dose. No defect or damage on the syringe was noticed. No screwed problem was detected when screwing the needle on and customer did not continue to attempt to screw it on (perhaps stripping the locking mechanism). The luer lock device did not began to spin around the syringe cone and did not hold the luer lock device in place when attaching the needle. The needle which was used was available and nurse also returned the needle.