This mdr was generated under protocol b10009704 as a result of warning letter cms#: 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The device was received for evaluation.Visual and functional testing were performed.Visual inspection confirmed that the needle had become detached from the needle hub.No issues were found with the introducer needle which was returned.The incoming inspection records were reviewed.No issues were found during inspection.The supplier of the needle which was returned from the customer was made aware of this issue and a supplier corrective action report was issued to the supplier.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.Udi, 510k are unknown.No product information has been provided to date.
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