BD ALCOHOL SWABS

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALCOHOL SWABS EXPERIENCED ILLEGIBLE LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 326895 BATCH NO: 0009098 & 9310438. DURING PRODUCTION, IT WAS FOUND THAT THE ALCOHOL PADS WERE DISCOVERED TO HAVE NON-LEGIBLE PRINTED LOT NUMBER AND EXPIRATION DATES. ADDITIONALLY, ALCOHOL PADS WERE FOUND WITH EXCESSIVE PLEATING AROUND THE SEALED EDGES, WHICH ALLOWED FOR LEAKAGE OF ALCOHOL FROM THE POUCHES.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/10/2020. H.6. INVESTIGATION: CUSTOMER RETURNED SIX (6) SEALED/UNUSED BD ALCOHOL SWABS FROM LOT 0009098 (3 FROM LINE 9 AND 3 FROM LINE 10). NO SAMPLES FROM LOT 9310438 WERE RETURNED, THEREFORE, THE ALLEGED ISSUES COULD NOT BE CONFIRMED FOR LOT 9310438. CONSUMER REPORTED THAT ALCOHOL PADS HAVE NON-LEGIBLE PRINTED AND NUMBER AND EXPIRATION DATES. IT WAS ALSO REPORTED THAT PACKAGES HAD EXCESSIVE PLEATING AROUND THE SEALED EDGES, WHICH ALLOWED ALCOHOL TO LEAK. ALL 6 RETURNED ALCOHOL SWABS WERE EXAMINED AND OPENED, AND NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED; NONE OF THE RETURNED SWABS WERE DRY OR EXHIBITED LEAKAGE. SINCE NO DEFECTS WERE OBSERVED THE ALLEGED ISSUES COULD NOT BE CONFIRMED FOR SAMPLES FROM LOT 0009098. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0009098. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9310438. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0009098, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-09, MEDICAL DEVICE LOT #: 9310438, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-11-06.

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALCOHOL SWABS EXPERIENCED ILLEGIBLE LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 326895 BATCH NO: 0009098 & 9310438. DURING PRODUCTION, IT WAS FOUND THAT THE ALCOHOL PADS WERE DISCOVERED TO HAVE NON-LEGIBLE PRINTED LOT NUMBER AND EXPIRATION DATES. ADDITIONALLY, ALCOHOL PADS WERE FOUND WITH EXCESSIVE PLEATING AROUND THE SEALED EDGES, WHICH ALLOWED FOR LEAKAGE OF ALCOHOL FROM THE POUCHES.