Sex: U
Vaccine: HIBV
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: Two others as we go to push it, we lose the medication; What problem are you having with the syringes, the hub of the syringe so it is two separate parts; give a shot and the entire hub came off as we went to push it; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a patient who received Hib (Hiberix) (batch number F45JY) 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 underdose (Verbatim: Two others as we go to push it, we lose the medication), syringe issue (Verbatim: What problem are you having with the syringes, the hub of the syringe so it is two separate parts) and pharmaceutical product complaint (Verbatim: give a shot and the entire hub came off as we went to push it). The outcome of the underdose, syringe issue and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 18-APR-2024 and 25-APR-2024 The reporter was a nurse from a pediatrics office reported a complain about the Hiberix vial/prefilled syringe presentation. She stated that she already reported this to the GlaxoSmithKline representative. The office has stopped using the diluent syringes that come with the product to administer to patients.  They were instead transferring the reconstituted product to a different syringe prior to administration and asked did you have to waste any. Except for one or two we were able to use them and what problem are you having with the syringes. The hub of the syringe so it was two separate parts you have the syringe and you have got the hub and assume it was supposed to be heated onto the top, well that hub spins.  Even when take the top protective cap off to put a needle on, that hub was starts spinning, so what was happening that with that hub spinning obviously it was not tight and they have had 2 to 4 instances.  One instance was they went to give a shot and the entire hub came off as went to push it. Two others as they go to push it, and lose the medication, which led to underdose. Two incidences have happened with reporter and the other 2 incidences were with other nurses but all three of the nurses are very experienced with preparing this product.  The defect was discovered before preparation, during preparation and during administration. The Luer-lock type needle was used. If the luer lock device began to spin around the syringe cone, the luer lock device in place when attaching the needle was hold. It was happening with all of them.  The reporter was showed to representative before the day of reporting, gave him like 4 different ones and took the top off of two, screwed the needle on and said here.  Then gave him two just straight out of the box, \she believes it is a design flaw, used the two got out. When reporter asked for the lot number of the box she handed the phone to someone else who read the lot number off the box as 2A95F and expiry date 20th January 2026 and off of another suspect syringe: M7422.  They requested that any affected syringes be sent back (up to 4) as well as the broken off hub if they still have it. Reported defect was classified as detached or rotating luer lock adapter. The reporter consented to follow up.