BD ALCOHOL SWABS

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: 1005682 WAS PROVIDED, HOWEVER, THIS IS NOT A BATCH FOR THIS PRODUCT. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN INVESTIGATION SUMMARY: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR MISSING LABEL INFORMATION (EXPIRATION DATE MISSING FROM SHELF CARTON) DUE TO UNKNOWN LOT NUMBER. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. UNABLE TO PERFORM A DHR REVIEW DUE TO AN UNKNOWN LOT NUMBER. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT THE EXPIRATION DATE DID NOT APPEAR ON PACKAGING AND WAS DISCOVERED PRIOR TO USE WITH A BD ALCOHOL SWABS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER CALLED REGARDING EXPIRATION ON BD ALCOHOL SWABS, STATED THAT THERE IS NO EXPIRATION DATE ON THE BOX.