Sex: U
Vaccine: FLU3
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: A small amount leaked once the needle was detached the plunger; needle of the Flulaval vaccine has remained in the arm of a pediatric patient/stuck needle; Luer lock is not grasping the needle appropriaterly; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in an unspecified number of patients who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 2XK44, expiry date 13-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received FluLaval 2024-2025 season (unknown arm). On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental underdose (Verbatim: A small amount leaked once the needle was detached the plunger), accidental needle stick (Verbatim: needle of the Flulaval vaccine has remained in the arm of a pediatric patient/stuck needle) and syringe connection issue (Verbatim: Luer lock is not grasping the needle appropriaterly). The outcome of the accidental underdose, accidental needle stick and syringe connection issue were unknown.   It was unknown if the reporter considered the accidental needle stick and syringe connection issue to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the accidental needle stick and syringe connection issue to be related to FluLaval 2024-2025 season and Flulaval 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: 06-SEP-2024 The healthcare professional (HCP)/ practice manager reported product complaint for Flulaval Trivalent vaccine (NDC: 19515-810-52). The HCP was an experienced user and reports that a video was taken of the scenario. The GSK agent contacted medical facility and spoke with the HCP/registered nurse involved in the preparation (customer 1). The HCP reports that there had been a few instances (unknown/unspecified) where the needle of the Flulaval vaccine has remained in the arm of a pediatric patient (stuck needle). To keep this from happening when prepping the vaccine, the staff has tried to turn the needle a little tighter, but it did not take much for the threaded port to popoff. Luer lock was not grasping the needle appropriately. The HCP reported that the type of needle used was a one inch with physical retraction. The defect discovered during preparation and injection. HCP reports that the suspect product was discarded. The needle was attached clockwise and it was not pushed. The needle was used 25 gage1 inch needle. A small amount of leaked once the needle was detached the plunger. there was some type of leakage, which led to accidental underdose. The HCP states that there was some type of leakage. HCP reports a small amount was leaked once the needle was detached from the plunger. This case had been link with US2024111400, reported by the same reporter.; Sender's Comments:  US-GSK-US2024111400:Same reporter/Different patient