Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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H.6.Investigation summary: bd has not been provided with photos or samples for catalog 405148 to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.Needle 22ga x 5in quincke catalog 405148 is a sterile material, packed individually into a blister.Blister contained a needle with the stylet and a shield cover.No "mayo" cover was sent as part of bd juncos for this catalog.During assembly process, catalog goes to a final stage (station 15) in which shield is assembled onto the cannula.The needle is packed at multivac machine in which has a vision system that inspect 100% the units and rejects if it detects an empty package, missing components (shield or needle/stylet) and/or orientation of the needle.A sterilization impact assessment was performed to evaluate if there is an impact on the sterilization assurance level (sal) when a missing component is reported for catalog 405148.Although the lot is unknown, the sterilization exercises demonstrate that the sterilization process is effective and capable of sterilizing the product at acceptable levels.In conclusion, the reported issue does not represent a single incident that would trigger any correction and preventative action at this time.H3 other text : see section h.10.
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