Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LJ5280 | — |
the adaptor is damaged or broken when trying to administer it; the adaptor is damaged or broken when trying to administer it; This is a spontaneous report received from an Other HCP from product quality group. No patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), (Lot number: LJ5280, Expiration Date: 30Apr2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE CONNECTION ISSUE (non-serious), outcome "unknown" and all described as "the adaptor is damaged or broken when trying to administer it". The reporter considered "the adaptor is damaged or broken when trying to administer it" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "the adaptor is damaged or broken when trying to administer it" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: the reporter was unable to administer PREVNAR 20 to the patient and it looked like the adaptor was damaged or broken when trying to administer it. Reporter stated that it was only one dose. NDC reported as "00052000-01".