Mdr 9618003-2021-01986 / device 1 of 2.Complainant street address: (b)(6).Complainant city: (b)(6).Complainant state/province: (b)(6).Complainant postal code: (b)(6).Patient country: (b)(6).Complainant phone: (b)(6).Correction: contact office address: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.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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Batch record review: lot 9j04790 was manufactured on 10/04/2019, product description duoderm xthin drs 10x10cm (1x10pk) nai, in bodolay line, with a total of 27,000 market units.A batch record review on 10/03/2021, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct.The batch record review supports that there were no discrepancies related to the issue reported.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.Conclusion summary of the related event: based in the analysis phase conclusions, the issue of wnd-pmc 9.6 primary pack has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination, or dressing or loose material is trapped in packaging, for products manufactured at bodolay pratt c packaging line, are attributed to the following probable causes per failure mode: for region not sealed the root causes found were: machine: misalignment of the sealing station: the misalignment of the sealing station was found as the second major contributor for the open seal (compromised sterile barrier) affecting the regions not sealed on products packed on bodolay pratt c due to the following opportunities: incorrect height of the upper sealing tooling: there was an opportunity found related to the proper high of the upper tooling of the sealing station.Currently this height is not standardized as part of the machine set up and it is a source of variation.1- malfunction of cylinders: during the investigation it was confirmed that cylinders in bad condition apply a wrong pressure during the sealing of paper and film.The preventive maintenance program of the machine was revised, and it was found an opportunity related to the non-standardized useful life of cylinders.Non-standardized use of teflon on sealing plate: current sealing tooling use teflon as a conductive of heat and to avoid paper or film to burn during the sealing of the blister.An opportunity was found because the number of layers of teflon to be used on the sealing plate has not been standardized.A capa plan will be generated for mitigate the root causes identified.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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