SWAB ALCOHOL 100 BX 1200

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) , USA HAS BEEN USED AS A DEFAULT. 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. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A CARTON OF SWAB ALCOHOL 100 BX 1200 HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS NO EXPIRATION DATE ON SHELF CARTON. VERBATIM: CONSUMER CALLED STATING SHE HAS A BOX OF THE BD ALCOHOL SWABS WITH NO EXPIRATION DATE ON THEM. CONSUMER PROVIDED LOT # AND THEN STATED SHE HAD ANOTHER CALL COMING IN AND WOULD HAVE TO CALL BACK. CALL WAS THEN DISCONNECTED, NO ADDITIONAL INFORMATION OBTAINED. LOT # 1034673, CAT # 326895. DATE OF EVENT: UNKNOWN. SAMPLES: UNKNOWN".

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT A CARTON OF SWAB ALCOHOL 100 BX 1200 HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS NO EXPIRATION DATE ON SHELF CARTON. VERBATIM: CONSUMER CALLED STATING SHE HAS A BOX OF THE BD ALCOHOL SWABS WITH NO EXPIRATION DATE ON THEM. CONSUMER PROVIDED LOT # AND THEN STATED SHE HAD ANOTHER CALL COMING IN AND WOULD HAVE TO CALL BACK. CALL WAS THEN DISCONNECTED, NO ADDITIONAL INFORMATION OBTAINED. LOT # 1034673, CAT # 326895, DATE OF EVENT: UNKNOWN, SAMPLES: UNKNOWN"