Sex: U
Vaccine: HIBV
Symptoms: Syringe issue, Underdose
Clinical narrative: some liquid came out between the luer lok device and the needle; Syringe leak; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a patient who received Hib (Hiberix) (batch number M7422) 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 accidental underdose (Verbatim: some liquid came out between the luer lok device and the needle), syringe leak (Verbatim: Syringe leak) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe leak to be related to Hiberix.     It was unknown if the company considered the syringe leak to be related to Hiberix.   Additional Information: GSK Receipt Date: 10-JUN-2024 The nurse was reporting 3 different issues with 3 Hiberix vaccines. The reporter was not the nurse who experienced the issues. According to reporter, the preparer was an experienced nurse. All 3 syringes were discarded, no pictures were available. The reporter did not provide the lot from the box, instead the lot from syringes was provided and it's the same for the 3 doses. The syringe 1 had an issue when administering vaccine to a patient, some liquid came out between the luer lok device and the needle which led to accidental underdose and syringe issue. Patient was not re vaccinated per doctor order. The patient demographics was unknown. The reporter asked that was the syringe pre-assembled with needle some time before administration, right before administration what size gauge needle was used, 23 G 1 inch (luer lok), was the blister or carton damaged, the reporter did not know if leaking from plunger stopper, are there any liquid traces observed on the plunger stopper rings, was the luer lock damaged, if so, describe in detail the needle connection procedure applied did you experience a rotating or detached luer lock adaptor when screwing the needle on the syringe prior to the leakage observation, the reporter did not know was the needle which was used, available. No, was there any damage or breakage on the syringe barrel, the reporter did not know. The syringe 2 had issue that the syringe plunger was too loose when trying to pull back reconstituted vaccine, plunger completely fell out and vaccine was lost. What part of plunger was loose rod or stopper, rod was the defect related to the plunger rod, to the plunger stopper or to both, plunger rod was the plunger loose or did it fall out completely, loose then fell out completely if fell out completely, at what point or step did this occur. During aspiration did the detachment happen during use or was it found detached in the sealed blister, during use were liquid and or dried liquid traces found in the blister, the reporter did not know. Syringe 3 had issue that when uncapping the needle to administered vaccine, the luer lok completely detached from the syringe. The nurse used another syringe and needle to administer vaccine to the patient. The reporter asked what type of needle was used, Luer lok needle 23 G 1 inch did any leaking occur during this step and if so, where was the leak location, since only 1 dose was lost, credit would be completed for 1 dose only. Credit was still pending. The reporter did not consent to follow up.