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 an investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised, and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Photograph, video and/or physical sample evaluation: ¿ there is a photograph associated with this case and in this, the reported defect can be seen.No unused return sample was expected.Batch record revision results: lot 1e02594 was manufactured on 25 may 2021, in aop6 line, with a total of (b)(4) market units (mkus).The compliance engineer performed a batch record review on 27/sep/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 identification (id) 1703746 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).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 27/sep/2023, compliance engineer ran a query in database in order to verify the complaints reported for the 1e02594 lot for the malfunction ¿pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿ and as result, no additional complaints were identified during this search as per work instruction (wi).Historical nonconformance review: on 27/sep/2023, compliance engineer ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction ¿pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿ for the lot number 1e02594 and as result, no nonconformance / capa (s) for this malfunction 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: test methods (tm-014) ¿pouch non-conformities¿: ¿ frequency: 80 pouches per turn (10 pouches per hour) ¿ sample quantity:(b)(4).¿ acceptance criteria: accept = 0 | reject = 1 defect rate analysis: there have only been 30 defective parts 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 (b)(4) based on our standard operating procedure (sop) ¿quality inspection 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 acceptable quality level (aql) of (b)(4).This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Conclusions: the review of the batch record for lot 1e02594 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 ¿pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿.No additional complaints were reported for lot affected related to the malfunction ¿pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿.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: 1049092 manufacturing site: 9618003.
|