Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Syringe issue
Clinical narrative: The product seems to be defective/ the Luer lock essentially would unscrew/ broken glass pieces; The initial case was missing the following minimum criteria: no adverse event, product complaint only. Upon receipt of follow-up information on (12Dec2023), this case now contains all required information to be considered valid.  This is a spontaneous report and received from Pharmacists from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM0172, Expiration Date: 28Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "The product seems to be defective/ the Luer lock essentially would unscrew/ broken glass pieces".  Causality for "the product seems to be defective/ the luer lock essentially would unscrew/ broken glass pieces" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Product Quality Group provided investigational results on 12Dec2023 for rsv vaccine prot.subunit pref 2v (device constituent): The complaint for "the Luer lock essentially would unscrew" of "ABRYSVO INJECTABLE (VACCINE)" was investigated. The investigation included reviewing the involved batch records, complaint sample, deviation investigation, evaluation of reference samples, 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 "HM0172". The reported defect was not 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 (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 on the returned complaint sample. No root cause or CAPA were identified as the complaint was not confirmed.  Additional information: Reportability updated from not reportable to 30 day reportable based on Site investigation 8651988 (closed on 12Dec2023) which showed broken glass pieces in the returned complaint sample. This is Medical Device Related. This complaint for reporter stated, "I just had a concern or a comment about one of the vaccines that we received and we are trying to utilize today, seemed kind of defective. The defect occurred with the Luer lock connection between the syringe and the vial once the adapter was connected to the vial. Once screwed together, the connection would not stay placed and the Luer lock essentially would unscrew (the vial/adapter and syringe come apart on their own). This was first assumed to be due to the pressure difference between the vial and the syringe, but air was removed from the vial and this was not found to be the case.