Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4932 | — |
the luer lock piece broke off when preparing it; This is a spontaneous report received from a Nurse. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4932, Expiration Date: 31Aug2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the luer lock piece broke off when preparing it". Additional information: Caller said the luer lock piece broke off when preparing it, it was before reaching the patient. Caller was putting this one together, then snapped off, it was the last one in the box. Caller got another one and administered that one to the patient. Clarified and confirmed the Prevnar 20 where the luer lock piece broke off was not administered to a patient. NDC: 0005-2000-01. Causality for "the luer lock piece broke off when preparing it" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).