BD ALCOHOL SWABS

Additional Manufacturer Narrative

THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6018764, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2016-01-18, MEDICAL DEVICE LOT #: 6078987, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2016-03-18, MEDICAL DEVICE LOT #: 6057858, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2016-02-26, MEDICAL DEVICE LOT #: 6078985, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2016-02-26. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBERS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT #S 6057858, 6078985, 6018764, AND 6078987 FOR MISSING LABEL INFORMATION (EXPIRATION DATE). THIS IS THE 1ST RELATED COMPLAINT FOR MISSING LABEL INFORMATION (EXPIRATION DATE) ON THESE LOT #S. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT 4 BD ALCOHOL SWABS EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 326895 BATCH NO: 6018764, 6078987, 6057858 AND 6078985. I WAS TRACKING DOWN SOME EXPIRATION DATES FOR ALCOHOL SWABS THAT WE HAVE ON HAND. I UNDERSTAND THAT THE NEWER PURCHASED THAT WE HAVE FOR YOU ALREADY HAVE THIS INFORMATION PRINTED ON THE BOTTOM, BUT THESE BOXES WERE FROM A TIME BEFORE THAT STARTED HAPPENING AND ONLY HAVE THE LOT NUMBER ON THE BOTTOM.