BD SWAB ALCOHOL

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY : 1. EXEC SUMMARY - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SHELF CARTON MISSING LABEL CONTENT (EXPIRATION DATE) AND FOR PACKET MISSING LABEL CONTENT (EXPIRATION DATE) ON THIS LOT #. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. 2. CAPA/SA - BASED ON THE ABOVE NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. 3. DHR REVIEW - OWING TO THE BATCH BEING MANUFACTURED IN 2013 AND FILES ARE RETAINED FOR 7 YEARS NO DHR REVIEW CAN BE COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT 2 BD SWAB ALCOHOL PRODUCTS HAD LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   THE CONSUMER STATED THAT THERE WAS NO EXPIRATION DATE ON THE BOX OR PACKAGES (PADS). DATE OF EVENT : UNKNOWN. SAMPLES : NOT AVAILABLE.