There were three (3) occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2022-00036.2245270-2022-00038.The supplier was contacted for an investigation and response.The response is as follows: we purchased ((b)(4)) units of dss-010-045 (prcgm038862) and (prcgm038863) from approved supplier; however ((b)(4)) units shipped to vygon us and the remainder units shipped to other customers.Vygon us had two complaints for the product, saturation level for the occurrence is 0.1%.We did not receive any complaint for the remainder units that have been shipped to other customers; therefore, overall saturation level is 0.08%.No adverse event occurred according to the customer.Dhrs has been reviewed for main product and subcomponents; there was no abnormality or nonconformance recorded.All parts manufactured according to internal drawings.The customer was not able to provide a photo for the complaint and the end user discarded the sample; therefore, investigation conducted per dhrs review.Investigation per dhr shows that there were no abnormality or discrepancy during manufacturing process.We can't perform evaluation without complaint sample, this complaint can't be confirmed.Device history record shows that all processes were performed as specified.Device history record shows that all equipment and material used are as specified.No incidents recorded at time of manufacture.A review of vygon's complaints showed this is the second issue with the introducer peeling associated with this product code over the past two years.Corrective action: due to the missing sample, the root cause of this issue could not be confirmed.Therefore, no corrective action will be initiated at this time.This failure will be monitored for future actions.
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