Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LP4948 | — |
one of the vial was broke; This is a spontaneous report received from an Other HCP 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, Device Expiration Date: 31Aug2026. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "one of the vial was broke". Additional information: A nurse practitioneris calling in regards to Prevnar 20 stated that they open a box of 10 yesterday(on 29Jul2025) and one of the vial is broke. When probed if there was any patient involvement, reporter stated, no, that was not administer. She had actually got the vial here in her office, in her possession. Prevnar 20 in tin, one of the vials arrived broken. Reporter was informed not to discard the product as the report will be forwarded for review by our Quality department.? Reporter stated okay. Reporter stated, a sample of the product available to be returned, she had got it right in front of her and she would not discard it. She will keep it. Reporter stated, packaging sealed and intact. When they opened the box, then they discovered that one because it was brand new tin vial box and so that was the only one that was broken. Reporter stated, no additional lot numbers, this is the only one. Sample not requested due to sharps risk. Product strength and count size dispensed: Reporter stated, "It is the Prevnar 20. It says 1 dose 0.5 ML.". Product NDC# 0005-2000-01. Causality for "one of the vial was broke" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).