(b)(4).Investigation results: initial reporter indicated six devices of the same lot number exhibited the reported sharp edge at the drill hole/perforation.Six devices were returned for investigation.Three were in an open and used condition, the other three were returned unused in the original package.The three opened devices all have different manufacture dates, which indicates they are from different lots and none of them share the same manufacture date / lot number of the products returned in package (all three packaged are from same lot number).A device of the same lot, returned by the customer was investigated related to this medwatch report.It was determined that the investigated device displayed no visible damage.Latex examination gloves were used to test to determine if sharp edge existed, the gloves were not damaged.The lot number of this device was not provided, therefore, review of device history records for this lot number could not be completed.Review of device quality and manufacturing records were checked for the reported lot number (4509784027) and were found to be according to specification valid at the time of production.No similar incidents were reported for this batch number.
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