Sex: M
Vaccine: HIBV
Symptoms: Device connection issue, Exposure via skin contact, Injury associated with device
Clinical narrative: Hiberix was being given to a infant when the needle popped off and stuck in the infants left leg; Skin Exposure; Once the medication was being pushed in the infants leg it splattered all over the infants leg; entire Luer Lock Adaptor and attached needle pop off the end of the pre filled syringes; 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 2-month-old male patient who received Hib (Hiberix) (batch number 5347Z, expiry date 14-MAR-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient did not receive Hiberix (left thigh). On an unknown date, immediately after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: Hiberix was being given to a infant when the needle popped off and stuck in the infants left leg), exposure via skin contact (Verbatim: Skin Exposure), inadvertent exposure to vaccine (Verbatim: Once the medication was being pushed in the infants leg it splattered all over the infants leg), syringe connection issue (Verbatim: entire Luer Lock Adaptor and attached needle pop off the end of the pre filled syringes) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental needle stick was resolved and the outcome of the 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: 16-APR-2024 The licensed practical nurse reported a product complaint with related adverse events. When the nurse was administering dose the entire luer lock adaptor and attached needle pop off the end of the pre filled syringes. Hiberix was being given to a infant when the needle popped off and stuck in the infants left leg. Once the medication was being pushed in the infants leg it splattered all over the infants leg, which led to exposure via skin contact and inadvertent exposure to vaccine. The reporter did confirm there was no damage due to shipping. Confirmation that all operations were performed appropriately before defect was discovered. The defect was discovered during administration. The mixing/shaking was done by gently shaking. The vial held upside-down when the vaccine was being withdrawn. The dose was not administered. The healthcare professional (HCP) stated that after the needle/luer lock adaptor pops off, the administrators were able to use an other syringe of medication and administer the doses. The HCP's were all experienced users. Clearly describe which component was impacted (e.g. prefilled syringe or vial). The luer lock adaptor was the component impacted. A picture of the defect would be sent to the email address provided from content.  Could not attach needle to syringe or luer lock defect. The type of needle was used, Safety Needle 25G 5/8 inch luer lock. No any defect or damage on the syringe noticed. When removing the cap, was it pulled off or screwed off (as it should be). The cap was screwed off. How was the needle connected, the needle was screwed on the luer lock device. If a problem was detected when screwing the needle on, did the customer continue to attempt to screw it on (perhaps stripping the locking mechanism) N/A. If a problem was detected when screwing the needle on, did the customer continue to attempt to screw it on (perhaps stripping the locking mechanism) N/A. The needle which was used, available and would be sent back to GSK.