Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LP4948 | — |
Damaged prefilled syringe / The plunger was broken when they went to unscrew and was not able to put needle tip on; This is a spontaneous report received from a Physician from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LP4948, Expiration Date: 31Aug2026) for immunisation, Device Lot Number: LP4948. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Damaged prefilled syringe / The plunger was broken when they went to unscrew and was not able to put needle tip on". The reporter considered "damaged prefilled syringe / the plunger was broken when they went to unscrew and was not able to put needle tip on" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "damaged prefilled syringe / the plunger was broken when they went to unscrew and was not able to put needle tip on" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).