BD ALCOHOL SWABS

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. INVESTIGATION CONCLUSION: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 0345775 FOR PACKAGE PRINTING DEFECT. THIS IS THE 1ST RELATED COMPLAINT FOR PACKAGE PRINTING DEFECT ON LOT # 0345775. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0345775. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. T THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT THE BD ALCOHOL SWABS EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION OR ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:326895 BATCH NO: 0345775. CONSUMER REPORTED SWABS DRY, ALSO STATED THAT THE INK ON THE PACKAGES IS SMEARED. CONSUMER WAS UPSET BECAUSE THIS IS THE 2ND BOX THAT HE PURCHASED AND HE IS HAVING THE SAME ISSUE. HE SAID HE WANTS THE PHARMACY TO REMOVE THE ALCOHOL SWABS FROM THE SHELF BUT THEY REFUSED AND TOLD THE CONSUMER THAT NO ONE ELSE COMPLAINED ABOUT THE SWABS. DATE OF EVENT: UNKNOWN.