Sex: F
Vaccine: RSV
Symptoms: Device leakage, Underdose
Clinical narrative: when she tried to push the adapter the medication leaked; when she tried to push the adapter the medication leaked; vial adapter did not go through the base properly; This is a spontaneous report received from a Pharmacist from product quality group.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 14Nov2023 as dose number unknown, single (Lot number: HM0167, Expiration Date: 28Feb2025) for immunisation, Device Expiration Date: Feb2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UNDERDOSE (non-serious), DEVICE LEAKAGE (non-serious) and all described as "when she tried to push the adapter the medication leaked"; DEVICE CONNECTION ISSUE (non-serious), described as "vial adapter did not go through the base properly". Causality for "when she tried to push the adapter the medication leaked" and "vial adapter did not go through the base properly" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: NDC number of Abrysvo: 0069-0344-05; UPC number of Abrysvo: 300690344058. Reporter mentioned that when she was using or diluting the Abrysvo convert the vial adaptor did not go on the base properly and it did not attached. So when she tried to push the adapter the medication leaked. She would like to ask for a replacement for the vaccine. The vial that has trouble yesterday was administered to a female patient. The sample was returned on 01Dec2023.  Product Quality Group provided investigational results on 28Dec2023 for Abrysvo. Conclusion: The complaint for the vial adaptor did not go on the base properly and it did not attached of Abrysvo injectable (vaccine) was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, evaluation of reference samples 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 HM0167. 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. Site name withheld concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative 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 (#withheld) is ongoing and will be followed through action item PR8754431.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received. Follow-up (22Dec2023): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (28Dec2023): This is a follow-up report from product quality group providing investigation results.  Updated information included: suspect drug Expiration date updated, Batch and lot tested and found within specifications check box ticked. New product complaint number added in references.  Follow-up (28Dec2023): This is a follow-up report received from product quality complaints group. This report included that:  Updated information included: New product quality complaint number added in references.The reassessment of this Non-Reportable event, has led to upgrading the event to Reportable.