Sex: F
Vaccine: HIBV
Symptoms: Device connection issue, Product preparation issue
Clinical narrative: Leur Lock Adaptor device where they would screw the needle onto are very unstable will wiggle and will fall off; Inappropriate Reconstitution Technique; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of syringe connection issue in a female patient who received Hib (Hiberix) (batch number 2A95F, expiry date 20-JAN-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced syringe connection issue (Verbatim: Leur Lock Adaptor device where they would screw the needle onto are very unstable will wiggle and will fall off), wrong technique in product usage process (Verbatim: Inappropriate Reconstitution Technique) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the syringe connection issue, wrong technique in product usage process and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe connection issue to be related to Hiberix.     It was unknown if the company considered the syringe connection issue to be related to Hiberix.   Additional Information: GSK Receipt Date: 03-JUN-2024 The reporter was a registered nurse called to report 5 doses of Hiberix where the Leur Lock Adaptor device where they would screw the needle onto were very unstable would wiggle and would fall off.  The reporter stated that they had to waste 1 dose, the first time this occurred (Lot ED9P2; Expiry: 9/30/2025).  With this first dose, they did not mix the saline diluent component in the prefilled syringe, with the Antigen component, as the saline diluent all came out of the syringe. After this first time, the preparers at the doctor's office started drawing up the vaccine component into a different syringe to administer the vaccine.  It was not confirmed which lot went with how many of the other 4 doses.  The reporter just said 5 suspect doses and these 2 lots were provided.  They did confirm there was no damage due to shipping that a Leur Lock needle was used for all 5 suspect doses.  The confirmed if healthcare professional preparing/administering vaccine were a new or experienced user. The preparers were all experienced users. They did review the product instructions for use step by step. A picture of the defect would be sent to the email address provided from content.  Confirmation that all operations were performed appropriately before defect was discovered.  The defect was discovered at the step was discovered was during preparation.  The first dose that was wasted was in the middle of a multi pack. It was unknown where the other suspect doses were in the multi pack.  The last 4 suspect doses were all administered but using a different syringe to draw up the vaccine. The first dose where the saline diluent all came out of the prefilled syringe was not used for administration. The leur lock adaptor device of the saline diluent prefilled syringe was the component impacted.  Luer lock adaptor (LLA) was detached or rotating while attaching the first needle for reconstitution and safety needle was used (BD Eclipse Needles 23G x 1 in). The customer did not continue to attempt to screw it on (perhaps stripping the locking mechanism. The reported did confirm the needle was screwed onto the leur lock adaptor hub per product instructions. The other 4 suspect doses were not wasted at all, and no leaking occurred. All suspect doses were wasted and were not available for return. No credit was requested for any of the 5 reported doses of Hiberix.  The reporter consented to follow up.