Additional information - this emdr is being submitted to include the below: h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary photograph, video and/or physical sample evaluation: there are photographs associated with this case and in these, the reported defect can be seen.No unused return sample was expected.Batch record revision results: lot 1k00313j was manufactured on 10/6/2021, in convex 1 pc line, with a total of (b)(4) mkus.The compliance engineer performed a batch record review on (b)(6) 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 (b)(4) and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instruction (pi) and recorded in br31-146 ver.7.0.Review of the batch record showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancy related to this issue were found within the documentation.Historical complaints review: on (b)(6) 2023, compliance engineer ran a query in database in order to verify the complaints reported for the 1k00313j lot for the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ and as result, no additional type 2 complaints were identified during this search as per work instruction.Historical nonconformance review: on (b)(6) 2023, compliance engineer ran a query in database looking for any in process nonconformance / corrective action/preventive action (cap)a (s) associated to the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ for the lot number 1k00313j and as result, no nonconformance / capa (s) for this malfunction code were generated during the manufacturing process of the referenced lot.Current quality controls: based on the process instruction, the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: pd31-146 ¿dimensional wafer ctq¿: ¿ frequency: 16 pouches per turn (2 pouches per hour) ¿ sample quantity: 16 pouches per turn (first piece at start) ¿ acceptance criteria: accept = 0 | reject = 1 defect rate analysis: there have only been (b)(4) defective part confirmed to date from a lot size of (b)(4) products.This represents a defect rate of only (b)(4)%, which is well within an appropriate acceptable quality level (aql) for this defect which should be 2.5% based on our pd31-146 ver.2.0 ¿convex 1 pc sampling plan¿.In addition, all of the in-process testing on this lot did not find a single defective pouch, which confirms that the lot is unlikely to breach an aql of 2.5.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted aql level for this type of failure mode or defect.Conclusions: the review of the batch record for lot 1k00313j showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements, all applicable manufacturing and quality processes were followed, and no discrepancies or deviations were recorded.No changes to the end-to-end manufacturing process or components used during assembly of the batch were made.No nonconformity has been registered during the manufacturing process of the affected lot for the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿.No additional complaints were reported for lot affected related to the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿.Based on this, no negative trend was identified.Based on preliminary investigation results, there is no objective evidence that other products from this lot are impacted, and the issue appears to be isolated.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: (b)(4) manufacturing site: (b)(4).
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