BD ALCOHOL SWABS

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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. DUE TO THIS BATCH BEING MANUFACTURED IN 2011 AND FILES ARE RETAINED FOR 7 YEARS, NO DHR REVIEW CAN BE COMPLETED. 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 # 1147315 FOR MISSING LABEL INFORMATION (EXPIRATION DATE). THIS IS THE 1ST RELATED COMPLAINT FOR MISSING LABEL INFORMATION (EXPIRATION DATE) ON LOT # 1147315. DUE TO THE BATCH BEING MANUFACTURED IN 2011, FILES ARE RETAINED FOR 7 YEARS, NO DHR CAN BE COMPLETED. 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 SWAB EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THE EXPIRATION ON DATE NOT SEEN ON THIS BOX. FOUND WITHIN HER HOME. OPENED ONE OF THE PACKETS AND ITS WET. ITS DETERMINED FROM THE LOT # AND COPYWRITE DATE THIS BOX WAS MANUFACTURED IN 2011 AND IS EXPIRED. INFORMED THIS CONSUMER.