Brand name is unknown; no additional information was received.No product was returned, thus the failure mode reported was not confirmed and a root cause could not be determined.There was one sample remaining in stock from the lot number reported on this complaint.The sample was evaluated and tested per internal procedures.There were no visual defects identified.The sample passed the leak test and the pull test per the internal test procedures.The manufacturer purchases this device from a supplier.There are two supplier non-conformances recorded.One was recorded in (b)(6) 2018 due to a documentation error, ports' undersized dimensions, and the device failing the leak and pull tests.Using the risk matrix, this non-conformance was determined to be a very low overall risk.The second supplier non-conformance was recorded in (b)(6) 2020 due to the slits in the port not open.The supplier put in place a corrective action implementing a second poka-yoke to use during the in-process inspection to confirm the cut is present before devices are packaged.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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