BD SWAB ALCOHOL

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY CUSTOMER RETURNED AN IMAGE OF 4 ALCOHOL SWAB PACKETS FROM LOT 1021202. THE LOT AND MANUFACTURING DATES ARE SMUDGED ON 3 OF THE 4 PACKETS. THE SMUDGE SPREADS OUT FROM A CENTRAL POINT ON EACH OF THESE PACKETS AS IF FROM A LIQUID SMUDGING THE PRINTED CHARACTERS. THE SMUDGING ALSO OVERLAPS WITH A CREASE VISIBLE ON EACH OF THE AFFECTED PACKETS. THE CREASE ISN¿T NEARLY AS DISTINCT ON THE PACKET WITHOUT THE SMUDGING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #1021202. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE IMAGE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SWABS BEING DRY. ROOT-CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

Description of Event or Problem

IT WAS REPORTED THAT 2 BD SWAB ALCOHOL PADS HAD LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED MANY OF THE PACKETS DAMAGED SO THAT THE ALCOHOL CONTENT HAS LEAKED OUT AND DAMAGED WHERE THE MANUFACTURE DATE AND EXPIRATION DATE ARE PRINTED.

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. NEW JERSEY (NJ), USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT 2 BD SWAB ALCOHOL PADS HAD LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED MANY OF THE PACKETS DAMAGED SO THAT THE ALCOHOL CONTENT HAS LEAKED OUT AND DAMAGED WHERE THE MANUFACTURE DATE AND EXPIRATION DATE ARE PRINTED.