Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Device connection issue, Injury associated with device
Clinical narrative: one Flulaval TIV pre-filled syringe, and was stuck by the needle in her right hand due to this detachment of the LLA and needle when trying to engage the safety on the needle; Syringe issue; Product Complaint; the practice is no longer engaging the safety on the needle in order to keep using the Flulaval pre-filled syringes; This non-serious case was reported by a other health professional via call center representative and described the occurrence of needle stick/puncture in a 47-year-old female 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 19-NOV-2024, the patient received FluLaval 2024-2025 season. On 19-NOV-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced needle stick/puncture (Verbatim: the practice is no longer engaging the safety on the needle in order to keep using the Flulaval pre-filled syringes). On an unknown date, the patient experienced accidental exposure while administering drug (Verbatim: one Flulaval TIV pre-filled syringe, and was stuck by the needle in her right hand due to this detachment of the LLA and needle when trying to engage the safety on the needle), syringe connection issue (Verbatim: Syringe issue) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the needle stick/puncture, accidental exposure while administering drug and pharmaceutical product complaint were unchanged and the outcome of the syringe connection issue was unknown.   It was unknown if the reporter considered the needle stick/puncture 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 needle stick/puncture 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: 10-DEC-2024 The reporter was a medical assistant calling to report that the practice has had 6 Flulaval TIV pre-filled syringes, that all 6 doses, when the healthcare professional finish administering the doses and go to engage the safety on the needle, the entire needle and LLA fall off the end of the pre-filled syringes. The reporter stated that they did administer all 6 of these suspect doses and will administer 7 other doses from this same shipment. The reporter states that her GSK Field Representative asked all practice locations via email, to call GSK and ask to have all remaining doses in the practices for this lot replaced. The reporter stated that the GSK Field Representative states GSK was already taking care of this situation. The reporter stated that this practice has 420 unused Flulaval doses for return for replacement. The 433 quantity affected includes the 6 suspect doses, the 7 unused doses the practice will continue to use, and the 420 unused doses for return to GSK. The reporter did confirm there was no damage due to shipping. None of the 6 suspect doses were available for return, as the needles and the pre-filled syringes have all been disposed in Sharps. The healthcare professional administering the 6 suspect doses are all experienced. The Product Instructions for use were reviewed step by step. A picture of the defect cannot be sent, as the 6 suspect needles and syringes have all been disposed in Sharps. Confirmation that all operations were performed appropriately before defect was discovered. The reporter asked at what step was the defect discovered. The defect was discovered after administration for each of the 6 suspect doses, when trying to engage the safety of the needle. It was not known where the 6 suspect pre-filled syringes were located in the multi pack. The 6 suspect doses were all administered. The component involved in all 6 suspect doses was the LLA with the safety needles attached. Luer Lok Adaptor (LLA) was detached or rotating, at what step did the detaching or rotating of the LLA occur. The LLA was detached from the end of the 6 suspect pre-filled syringes when the healthcare professional were trying to activate the safety on the needle. During injection, did any leaking occur during this step and if so, where was the leak location, No. If the needles used were still available, request return of them along with the other components. None of the 6 suspect needles were available for return. The needle stick was on 19th November 2024. If safety needle used, what brand and type of safety needle was it, Terumo Sureguard 3. The reporter was asking for replacement for 420 doses of Flulaval TIV. The healthcare professional would call back with this information. Replacement was pending the account and the case will be escalated to team liaison. The reporter was a Medical Assistant calling to report that an HCP in the practice had a needle stick from one Flulaval TIV pre-filled syringe and was stuck by the needle in her right hand due to this detachment of the LLA and needle when trying to engage the safety on the needle. The reporter also stated that because of this concern, the practice was no longer engaging the safety on the needle in order to keep using the Flulaval pre-filled syringes. The reporter had reported all that was provided about these adverse events.