Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MA2502 | — |
Prevnar-20 Pediatric vial broke upon removing it from the box in preparation for administration; This is a spontaneous report received from a Nurse from product quality group. 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: MA2502, Expiration Date: 31Oct2026) for immunisation, Device Lot Number: MA2502, Device Expiration Date: 31Oct2026. 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 "Prevnar-20 Pediatric vial broke upon removing it from the box in preparation for administration". The reporter considered "prevnar-20 pediatric vial broke upon removing it from the box in preparation for administration" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "prevnar-20 pediatric vial broke upon removing it from the box in preparation for administration" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).