Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out; syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out; A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER BLINDED TRIAL This is a Pfizer sponsored interventional study report for protocol. A patient (age and gender not provided) was scheduled to receive investigational study product. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), SYRINGE ISSUE (non-serious), outcome "unknown" and all described as "syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out". Additional Information: The investigational product syringe sat for 15 minutes followed by preparation of syringe. The tip of syringe broke off when it was tapped with a pen to get the air bubble out. The patient did not receive a dose with the damaged prefilled syringe of the investigational product. The patient was able to successfully get another dose from a replacement kit. Product Quality Group provided investigational results on 29Aug2023 for investigational product: The PFS that resulted in the complaint was not returned for evaluation. The photo provided has been examined to provide a possible root cause for the investigation. The root cause is assigned as Non-assignable. There was no adverse event. There was no impact to dosing as a replacement kit was used to provide the dose. There is no change to the quality release status for this packaged lot. This observation will be monitored for tracking and trending purposes through the complaint process. The complaint is confirmed, and the root cause is assigned as Non-assignable. The pre-filled syringe (PFS) that resulted in the complaint was not returned for evaluation. There was a photo provided showing the syringe broken by the tip area. The IP Manual instructions address correct preparation steps. The risk files have considered the hazard situation associated, risk control measures and verification of implementation and effectiveness are in place and risk level after post-mitigation is of "low". Therefore, no further actions are required. The blind has been broken for Protocol due to end of study unblinding. The patient was randomized to receive PF-07307405. The investigator considered there was not a reasonable possibility that the event "syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out" was related to PF-07307405, solution for injection. It is unknown if the event "syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out" was related to clinical trial procedure. No follow up attempts are possible. No further information is expected.