Sex: U
Vaccine: RSV
Symptoms: Product container issue, Syringe issue
Clinical narrative: One of them leaked; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on [23Apr2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist 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 (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "One of them leaked".  Causality for "one of them leaked" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Summary of Investigation: The investigation could not indicate a probable root cause for the complaint to be related to the production process. All reviewed deviations indicated that the batches met the established requirements at time of release. However, without lot number and based on the limited available information it is not possible to perform a more profound investigation and/or root cause analysis. No related trend could be identified based on complaint history review. No impact assessment is required according to SOP-67372. No corrective or preventive actions were identified as all reviewed records met the established requirements at time of release.  The complaint for "one of them leaked" of Abrysvo Injectable (Vaccine) was investigated. The investigation included reviewing deviation investigation and an analysis of the complaint history for the product type. The final scope was determined to be the reported product and product type, as no lot was available. 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. Investigation concludes that the reported defect is not representative of the Pfizer (withheld) process quality and 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 caller is calling from (withheld) one of their 3 syringes of Abrysvo and one of them leaked, so she could not use it. "I want to report that and I wanted to know if you can send me a replacement? If you want to send me a replacement or if you want to credit my account because I already ordered 1 of them today. Because I ordered 3 to use for 3 patients but I had to use another one because one broke, so I don't have anything." As per agent and confirmed by caller, caller is calling about this product being broken and already disposed. Caller clarifies that when another pharmacist was trying to 'mix' the syringe, one of the vials broke. States she already reported this (doesnt have Rep ref #) and received a sharps container to return the broken vial. States she doesnt know what to do as that broken vial was already placed in their own sharps container along with other sharps. Caller reviewed paperwork received with sharps container sent by Pfizer however unable to locate ref #.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.