SWAB ALCOHOL 100 BX 1200 SPAIN

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. FDA DEVICE PROBLEM CODE: 2911 FDA PATIENT PROBLEM CODE: 2199

Description of Event or Problem

IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 SPAIN HAD A STAINED PRINTED LEGEND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENT REFERS THAT THE ALCOHOL TOWELS THEY USE TO INCORPORATE THEM INTO DIFFERENT MEDICATIONS HAVE A STAINED PRINTED LEGEND, THEY ASSUME THAT IT IS DUE TO ALCOHOL LEAKAGE ON THE TOWELS.

Additional Manufacturer Narrative

H.6. INVESTIGATION: CUSTOMER RETURNED (500) BD ALCOHOL SWABS FROM LOT 0100860 (50 FROM EACH LINE: LINE 1-10). CONSUMER REPORTED STAINED PRINTED LEGEND, THEY ASSUME THAT IT IS DUE TO ALCOHOL LEAKAGE ON THE TOWELS. 30 OUT OF THE 500 RETURNED SAMPLES WERE OPENED AND EXAMINED, AND IT WAS OBSERVED THAT NONE OF THE SWABS WERE DRY. NONE OF THE EXAMINED FOIL PACKETS EXHIBITED PRINTING DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0100860. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 SPAIN HAD A STAINED PRINTED LEGEND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENT REFERS THAT THE ALCOHOL TOWELS THEY USE TO INCORPORATE THEM INTO DIFFERENT MEDICATIONS HAVE A STAINED PRINTED LEGEND, THEY ASSUME THAT IT IS DUE TO ALCOHOL LEAKAGE ON THE TOWELS.