Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Syringe issue
Clinical narrative: syringe tip broken off with the luer lock still attached; The initial case was missing the following minimum criteria: product complaint only (no adverse event). Upon receipt of follow-up information on 07Mar2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9849, Expiration Date: 31Mar2025) for immunisation, Device Lot Number: HG1756, Device Expiration Date: 31May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "syringe tip broken off with the luer lock still attached".  Causality for "syringe tip broken off with the luer lock still attached" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.  Product Quality Group provided investigational results on 26Mar2024 for rsv vaccine prot.subunit pref 2v for Lot number: HM9849: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lots of the reported lot HM9849. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. PGS (withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Additional information: The physician who administers Abrysvo vaccine reported that there was a vial that contains medication and the syringe luer lock came off the syringe and was not able to use the vaccine since it spilled out. He  stated the syringe tip is what had broken off with the luer lock still attached on one of the syringes. The physician was asking for replacement for the product and states he will save this Abrysvo that had the luer lock come off the syringe and spilled out in the refrigerator to send back to Pfizer (sample is available to be returned with the packaging sealed and intact and agreed to return the reported product for further investigation). The physician used a new vial of Abrysvo to vaccinate the patient. The physician saved this defective syringe and the luer lock is disconnected. He has ordered at least 300 to 400 Abrysvo vaccines and this is unusual to happen. He states there has been no patient involvement with this Abrysvo. He used a different Abrysvo that was not defective to vaccine patient. He states he has had other Abrysvo vaccines that the luer lock didn't come off but was loose and did not find that defective. This was the first time it came off the syringe.