BD ALCOHOL SWABS

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS UNKNOWN:  (B)(6), USA HAS BEEN USED AS A DEFAULT.  INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. 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. INVESTIGATION CONCLUSION: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 3081193 FOR MISSING LABEL INFORMATION ON SWAB PACKET (EXPIRATION DATE). THIS IS THE 1ST RELATED COMPLAINT FOR MISSING LABEL INFORMATION ON SWAB PACKET (EXPIRATION DATE) ON LOT # 3081193. DUE TO THIS BATCH BEING MADE IN 2013 AND FILES ARE RETAINED FOR 7 YEARS, NO DHR REVIEW CAN BE COMPLETED. 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 CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT 20 BD ALCOHOL SWABS EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM # 326895 LOT # 3081193 FOUND 20 SWAB PACKETS THAT SHE KNOWS HAD FOR SOMETIME IN HOME. THE SWAB PACKETS DO NOT HAVE EXP DATES LISTED ON THEM. SHE WILL DISCARD THEM DETERMINED FROM LOT NUMBER OBTAINED FROM BACK OF PACKET SWABS MANUFACTURED MORE THAN 5 YEARS AGO.