Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: Problem with the diluent; plastic connector of this is only partially going into the stopper (was bending); connector on the side is actually splitting; tried 5 of them and none of them are working; The initial case was missing the following minimum criteria: product complaint. Upon receipt of follow-up information on 13Oct2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: HF5016, Expiration Date: 28Feb2025) and (Lot number: GY5655, Expiration Date: Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), outcome "unknown", described as "Problem with the diluent; plastic connector of this is only partially going into the stopper (was bending); connector on the side is actually splitting; tried 5 of them and none of them are working". The reporter considered DEVICE MALFUNCTION associated to device constituent of rsv vaccine prot.subunit pref 2v. Causality for DEVICE MALFUNCTION was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).   Additional information: The pharmacist mentioned that she was having a problem with the diluent of the rsv vaccine prot.subunit pref 2v. The pharmacist said that the plastic connector was only partially going into the stopper, and she could not have the vaccine diluted. The pharmacist also mentioned that she had already tried five connecters from this product (she meant from this box, from this particular box) but "all did not work, and this is first time this happen to them." The pharmacist stated, "Right, yes it looks like the connector is bending. Actually, the connector on the side is actually splitting. So, it's like not allowing you to go directly into the stopper like it should. So, it's not even allowing it to you know to go in and even puncture the stopper. So, yes and I tried five of them and none of them are working. Although, I have done many of these vaccines so, I know how to do it, but I was not able to even get the connection on any of them. So, I think there is just an issue with this particular one."  The pharmacist stated that the vaccine was not given to a patient. The pharmacist clarified "No, it was not. It was a new box, so it was the new box that I opened. No, I did not dispense anything from this box, so it was a new box."  New information received from the manufacturing site on 29Nov2023 has changed the reportability from not reportable to reportable. Sample evaluation revealed a broken vial adapter spike.   Investigation findings from Product Quality Complaints: Conclusion: The complaint for "The plastic connector of this is only partially going into the stopper." of "Abrysvo injectable (vaccine)" was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot "HF5016". The reported defect was present on the returned complaint sample. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. PGS (Site name 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 be confirmed on the returned complaint sample. No root cause or CAPA were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release. A supplier investigation (#) is ongoing and will be followed through action item PR8681314.