Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Device connection issue, Needle issue
Clinical narrative: stuck needle/ needle of the Flulaval vaccine has remained in the arm of a pediatric patient; the vaccine was partially administered to a 2-year-old male patient; Luer lock is not grasping the needle appropriately/ small amount leaked once the needle was detached the plunger; Product Complaint/ Luer lock is not grasping the needle appropriately/ needle was detached the plunger; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental needle stick in a 2-year-old male patient 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 (intramuscular, unknown arm). On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental needle stick (Verbatim: stuck needle/ needle of the Flulaval vaccine has remained in the arm of a pediatric patient), accidental underdose (Verbatim: the vaccine was partially administered to a 2-year-old male patient), syringe connection issue (Verbatim: Luer lock is not grasping the needle appropriately/ small amount leaked once the needle was detached the plunger) and pharmaceutical product complaint (Verbatim: Product Complaint/ Luer lock is not grasping the needle appropriately/ needle was detached the plunger). The outcome of the accidental needle stick, accidental underdose, syringe connection issue 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 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 HCP (health care professional) was an experienced user and reported that a video was taken of the scenario. GlaxoSmithKline agent contacted medical facility and spoke with the HCP/RN (health care professional/ registered nurse) involved in the preparation. The HCP reported 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 had 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. HCP reported that the type of needle used was a one inch with physical retraction.  The PQC questions were asked, and it was reported the defect discovered during preparation and injection.  The HCP reported that the suspect product was discarded. The reporter described that the needle was attached clockwise, it was not pushed on. The needle used was a 25 gage1 inch needle. The reporter also mentioned that a small amount leaked once the needle was detached the plunger, there was some type of leakage.  HCP reported that the vaccine was partially administered to a 2- year-old patient, which led to an accidental underdose. This case has been linked to the US2024AMR115341 case reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR115341:Same reporter/Different patient