A thorough investigation into the reported issue was conducted and the root cause of the reported problem was found to be related to the use of an additional/alternate supplier of the polyisoprene.The additional supplier was used so that there would not be just a single source supplier.Although the alternate supplier¿s product did meet specification, the investigation revealed that the original supplier¿s tear resistance was stronger for the same thickness control.As of october 2018 cardinal health reverted back to using only the original supplier.The device history record of the complaint lot was reviewed and the lot was inspected and released in compliance with all requirements.The lot number reported in this incident was produced prior to the corrective action of reverting back to the original supplier of the polyisoprene.We continue to monitor complaints for any trends, and to ensure that reverting back to the original supplier has resolved the issue.
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