Catalog number and udi are unknown.No information provided to date.This mdr was generated under protocol b10009704, as a result of warning letter cms#: 617147.No lot number was provided; therefore, device history record review could not be completed.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.No product sample was received; therefore, visual and functional testing could not be performed.Per pictures received, part of the cannula observed and some redness and edema noted on the skin.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.A corrective and preventative action has been opened to perform a complete root cause analysis of the reported failure mode.
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