Device 5 of 6.E1: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Returned sample evaluation: photos associated with this case were received for evaluation.Batch record review: lot 3e00390 was manufactured on 5/9/2023, in scd (surgical cover dressing) packaging line, with a total of (b)(4) units.The complaint investigator performed a batch record review on 24/nov/2023, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material id 1704503 and manufacturing order 1679130.The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: there are no photographs associated with this case.No unused return sample was expected.Conclusion summary of the related event: based on the revision of the observation of the processes involved, interviews to the personnel of the line and the expertise of the triage team, this failure mode was attributed to the following probable causes: method: the machine does not have a method for avoid performing the operation on out of the validated process ranges for temperature.Corrective and preventive actions (capa) identified will be taken through capa record in database.The investigation associated with related event record has been approved and was complete.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.
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