Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: cracked glass syringe barrels/cracked right below the LLA on the syringe barrel, broken, cracked and damaged syringe; product Complaint; partial doses were administered/Underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 64-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 57YT7, expiry date 11-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On 27-SEP-2024, the patient received FluLaval 2024-2025 season (intramuscular, left deltoid). On 27-SEP-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental underdose (Verbatim: partial doses were administered/Underdose). On an unknown date, the patient experienced syringe broken (Verbatim: cracked glass syringe barrels/cracked right below the LLA on the syringe barrel, broken, cracked and damaged syringe) and pharmaceutical product complaint (Verbatim: product Complaint). The outcome of the accidental underdose, syringe broken and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe broken to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the syringe broken 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: 27-SEP-2024 The reporter was a medical assistant calling to report that two other medical assistants in the practice each partially administered one suspect Flulaval TIV dose to separate patients. The reporter reported that two cracked glass syringe barrels, right under the LLA, for two doses of Flulaval TIV. The reporter mentioned that neither suspect product was available for return as both suspect doses had been disposed in sharps. The reported that he/she did confirm there was no damage due to shipping.  they did review the Package insert for step by step. The reporter thought that the syringes were cracked before administration, but the administrators were unaware. For both doses, the preparers were able to attach the Leur Lok needles, and partial doses were administered, which led to accidental underdose. They noticed the crack after partial administration for both suspect doses. The two HCP's preparing and administering both doses were experienced users. The reporter reported that a picture of the defects will not be sent, as the suspect doses had already been disposed in Sharps. It was confirmation that all operations were performed appropriately before defect was discovered. The reporter asked a questioned at what step was the defect discovered and the step at which the defect was discovered was during administration for both suspect doses they mentioned as the two suspect doses were in the exact middle of the box, next to each other and both suspect doses were partially administered. Both suspect doses were the glass right below the LLA component was involved in the complaint. The box or carton or blister tray were not damaged upon receipt. It was unknown there were any evidence of leakage or product in box or carton. The product was not present in the syringe. The reporter was told the crack or breakage observed right below the LLA, on the glass syringe barrel, for both suspect doses. It was unknown the gauge needle was used. It was unknown if the syringe hubs came broken. This case had been linked with US2024119910, reported by the same reporter.; Sender's Comments:  US-GSK-US2024119910:same reporter