Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: Two diluent adapter in the box have been defective; The initial case was missing the following minimum criteria: reportable adverse event. Upon receipt of follow-up information on 22Aug2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist and a Consumer or other non HCP 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: HN3801, Expiration Date: 31Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MATERIAL ISSUE (non-serious), outcome "unknown", described as "Two diluent adapter in the box have been defective".  Causality for "two diluent adapter in the box have been defective" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: reporter mentioned that she had a box that they had just received and the two diluent adapter in the box had been defective, she was not sure if the needle in the diluent adapter was situated at angle such that and it's not making a clear puncture into vial, also the syringe and extra content are after mixing, they were requesting for a replacement. Reporter believed that the adapter in two of the packages was defective but it was when the adapter was pressed into the rubber stopper for the vial, it did not make a clean straight perpendicular contact, unable to properly attach the diluent and withdraw the mixed vaccine on two of the packaging inside. Reporter believed that's because the adapter was defective, the adapter that attaches the diluent syringe to the powder vial had a defective needle inside the adapter, that was not making a clean perpendicular contact with the rubber stopper. The vaccine was not administered to any patient. Reporter used the adapter that was included in the Abrysvo kit, it was an adapter that was used to puncture the vial. It's provided as a kit from Pfizer so, there is a syringe that comes from Pfizer that is filled with diluent, there is an adapter and there is a vial that has the powder free constitution, reporter did not measure these things or puncture them themselves. The vaccine received as a new box, sealed new box and each individual kit inside is sealed. The involved complaint sample was received on 21Jun2024. Batch/lot number also reported as HC3598, Expiry Date of Abrysvo also reported as 31May2025.  Product Quality Group provided investigational results on 22Apr2024 for rsv vaccine prot.subunit pref 2v: MDCP Investigation Summary and Conclusion: The complaint of "I believe that the adapter in two of the packages is defective, but it is when the adapter is pressed into the rubber stopper for the vial, it does not make a clean straight perpendicular contact, unable to properly attach the diluent and withdraw the mixed vaccine on two of the packaging inside. I believe that's because the adapter is defective, the adapter that attaches the diluent syringe to the powder vial has a defective needle inside the adapter, that is not making a clean perpendicular contact with the rubber stopper" for Abrysvo SFDPO 5 x 0.5ml GVL + SYR was investigated by the manufacturing site: Manufacturing Investigation: 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. No corrective or preventive actions were identified as all reviewed records met the established requirements at time of release. Conclusion: The complaint for "adapter in the box have been defective" 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. (Name withheld) concludes that the reported defect is not representative of the Pfizer 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. Product Quality Group provided investigational results on 22Aug2024 for rsv vaccine prot.subunit pref 2v: Investigation Summary and Conclusion: The complaint for "adapter in the box have been defective" of Abrysvo Injectable (Vaccine) was investigated. The investigation included reviewing the involved batch records, complaint samples, deviation investigation and an analysis of the complaint history for the reported lot and product type. Quantity of returned complaint sample(s): 2 samples. The reported defect was not present on the returned complaint samples. The complaint is not confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety.  The NTM process determined that no regulatory notification was required. The final scope was determined to be the associated lot(s) of the reported lot HN3801. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. This investigation is based on the information captured in the Complaint Description and Argus Report. The Complaint Issue, Damaged Component, was reported. The damage interpreted to be bent spike within the vial adaptor based on the information provided "when the adapter is pressed into the rubber stopper for the vial, it does not make a clean straight perpendicular contact". The issue of "unable to properly attach the diluent and withdraw the mixed vaccine" is considered as a cascading effect of "Damaged Component" and therefore it will not be investigated. The Risk Management File was reviewed to confirm that the Hazard(s) and Hazardous Situation(s) associated with the Complaint Issue are documented in the Hazard Analysis (INX# 100366593, Version (7.0). The following associated Hazard(s)/Hazardous Situation(s) are documented: H03_188, Hazard "Functionality - Critical Performance"/Hazardous Situation "Delay while HCP prepares a second injection". Conclusion: The Hazard(s) and Hazardous Situation(s) associated with the Complaint Issue are documented in the Risk Management File. All complaint investigations are trended. There is no current trend alert documented.