Batch record review: lot 8d00477 was manufactured on 04/17/2018 in the guard line with a total of (b)(4) market units.Complaint investigator performed a batch record review on 02/08/2019 to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom (bill of materials), ds10-034 (system 5 drainable ostomy pouch with stomahesive skin barrier), process instructions (pouch disc collar assembly system 5 b (guard machine), and all the tooling information documented was also correct, under international commodity code (icc) code 22767 system application product (sap) material identification (id) 1003062 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Photo/sample analysis: no photos/samples were received related to the reported problem.Investigation conclusion: based on the investigation findings through revision of the batch records documentation, process observation, personnel interviewed, methodology implemented and defects simulation, the root cause could not be identified.Nevertheless, there is one (1) condition that could be considered, based on objective evidence, as a contributor factor for this event: there is not control in place for centering pins in the guard line.No issues related to machine, material, method, measurement or environment were identified during the manufacturing process evaluation, therefore no further actions are required related to these factors.The investigation associated with related event has been approved and is 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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