Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | AX4606A | — |
Pricked by needle; Luer-lock system not tightening properly/defect occurred; This spontaneous case, initially received on 10-Sep-2025, was reported by a health professional and concerns a female patient. Administration of company suspect drug: On an unknown date, the patient received Afluria (TIV) for Influenza immunization, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not reported, Lot number: AX4606A. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Sep-2025, the patient experienced Pricked by needle (outcome: Unknown), Luer-lock system not tightening properly/defect occurred (outcome: Unknown). The nurse reported that the treatment measures were taken associated with event as called worker's department and patient had blood work and confirmed that there were four or five, defective units may had more units they're tightened down a bit more no to see if that doesn't happen anymore and patient informed nurse confirmed that a total of 8 units had this issue and all vaccine hubs were loose and they have to tighten all of them all 100 boxes have the same lot and patient confirmed that was able to apply a full dose by nurse and confirmed Luer-lock system was not tightened, it spins and pops off and product was stored in original box with blister package Afluria (TIV) action taken: Not Applicable Reporter's assessment: The reporter (nurse) consider events as non-serious and causality assessment was not provided.; Reporter's Comments: The causality of events assessed as not related due to event nature (special situation)
Comments: None