Received Jul 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4929 | — |
Cap and like the little piece that you put the needle on, it come completely off and the medication leaked out; Cap and like the little piece that you put the needle on, it come completely off and the medication leaked out; The initial case was missing the following minimum criteria: This case has been considered invalid as Info not qualifying for AE reporting - Product Complaint: no indication that the consumer experienced an event under Product Prevnar 20. Upon receipt of follow-up information, this case now contains all required information to be considered valid. This is a spontaneous report received from a Nurse from product quality group. No patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown (Lot number: LN4929, Expiration Date: Jul2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "Cap and like the little piece that you put the needle on, it come completely off and the medication leaked out". The reporter considered "cap and like the little piece that you put the needle on, it come completely off and the medication leaked out" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "cap and like the little piece that you put the needle on, it come completely off and the medication leaked out" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: NDC Number: 0005200001. While taking the cap off, unscrewing the cap, the cap and like the little piece that you put the needle on, it come completely off and the medication leaked out. It was like the top of the glass vial broke in half. Packaging was sealed and intact. Follow-up (26Jun2025): This is a spontaneous follow-up report received from product quality group. Updated information: device reportability assessment; case has been considered valid.