Sex: M
Vaccine: HIBV
Symptoms: Device connection issue
Clinical narrative: needle stayed in his thigh until it was pulled out; leur lock was not tight after the needle was attached, it was loose where the luer lock attaches to the syringe; leak occured between the syringe and the Luer lock device; Product Complaint; This non-serious case was reported by a nurse via sales rep and described the occurrence of accidental needle stick in a male patient who received Hib (Hiberix) (batch number 73FP5, expiry date 06-DEC-2027) and (batch number 3E2XR, expiry date 20-JAN-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix (intramuscular, unknown thigh). On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: needle stayed in his thigh until it was pulled out), syringe connection issue (Verbatim: leur lock was not tight after the needle was attached, it was loose where the luer lock attaches to the syringe), syringe leak (Verbatim: leak occured between the syringe and the Luer lock device) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental needle stick was not reported and the outcome of the syringe connection issue, syringe leak and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick and syringe connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.     It was unknown if the company considered the accidental needle stick and syringe connection issue 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: 21-JUN-2024 The reporter was a nurse at a pediatric office. She was in charge of ordering vaccines. She reported that her GlaxoSmithKline sales representative informed her that there have been some Hiberix PQC reports and encouraged her to contact the response center if their office was having any issues. She reported that they had some problems with our Hiberix. The sterile diluent keeps popping off. We have had a couple incidences where it was popping off as we are mixing the vaccine and then we had one incident where it popped off in the patients leg while they gave it. The patient was not hurt but the needle stayed in his thigh until it was pulled out. Some were administered, some were not. A few of them could not be used because it popped off and spilled everywhere. The nurses had started using a different syringe to administer the product as a work-around to avoid this problem. Reporter said they were recently began ordering this product and so this is their first box. All incidents had occurred with this box. There was no suspect product to return (as all have been put in sharps container). No pictures were taken. Despite the fact that this was the first time the office had used this product the reporter indicated that the nurse was experienced (at preparing it). The defect was discovered during preparation.  It had happened before and it had happened after. It had happened with first needle and it had happened with the second needle. The needles used were BD Eclipse Needle 25 gauge (5/8 inch or 1 inch depending on child's leg size). Needle specified for use with Luer Lock syringes only. The needle was popping off with the luer lock still attached. The Luer Lock Adaptor (LLA) detached. The leak occured between the syringe and the Luer lock device. It was that part where you secure/screw the needle to, the threaded part, between the syringe and the lock. She indicated that the luer lock was the problematic part. Junction Syringe glass tip/LLA The complainant experienced difficulties to screw on the needle to the Luer Lock.  The nurses have told the reporter that the leur lock was not tight after the needle was attached, it was loose where the luer lock attaches to the syringe, that piece was not tight. The syringe did not came broken or did not it break when needle was being attached which led to accidental needle stick, syringe connection issue, syringe leak and pharmaceutical product complaint. It broke while the needle was being attached or in the case of the related adverse event it broke during administration. The box lot reported was 2A95F with expiry date 20th January 2026.