Manufacturer narrative: investigation result: after examining the actual device returned by the end-user, it was observed the needle cannula was bent in several locations, and there multiple substances attached.A large scratch was observed on the cannula which may have been caused when the needle was removed from the patient.It was observed that the hole in the needle hub from which the needle was attached was circular and no abnormality was found.There was an unidentified substance inside the needle hub at the attachment site, but as the needle shape remains it may have been caused after the needle was removed.The investigation was unable to identify a root cause for the needle separation by examining the returned device.Batch records were checked for the same lot and the product lot passed the final inspection pulling test.There were no other complaints reported for this issue for this lot number.There have been no similar complaints reported for this device family for the past three (3) years.As no root cause was determined, no corrective action will be taken.The investigation report is attached to this report for reference.We consider this file closed.Corrected data: section d10: device returned to the manufacturer date added.Section f7: supplemental report 001 selected.Section h10: narrative and corrected data added.Factory investigation report with attachments added to file.
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