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. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. (B)(4). INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. AS PER MANUFACTURING: DHRS ARE LEGALLY KEPT FOR 7 YEARS AFTER THE BATCH CREATION DATE. LOT NUMBER 0035593 WAS MANUFACTURED ON FEBRUARY 2010 (10 YEARS SINCE BATCH CREATION DATE), THUS THE DHR FOR THIS LOT NUMBER IS NO LONGER AVAILABLE. OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR MISSING LABEL CONTENT (EXPIRATION DATE) ON LOT # 0035593. A REVIEW OF RISK MANAGEMENT DOCUMENT 151RMN-0001-01 REVISION 01, INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (ALCOHOL SWAB, MISSING LABEL CONTENT (EXPIRATION DATE) WAS NOT CAPTURED ON THIS DOCUMENT. PLEASE REFER TO ATTACHED MEMO FOR QUALITY ENGINEERING ASSESSMENT. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS NO EXPIRATION DATE ON THE BOX OF BD¿ ALCOHOL SWABS, AND THE PRODUCT WAS LATER FOUND TO BE EXPIRED. THIS WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NO EXPIRATION DATE ON AN OLD BOX OF HIS BD ALCOHOL SWABS. STATED THE SWABS HAVE NOT BEEN OPENED OR USED. UNABLE TO LOCATE A COPYRIGHT OR TRADEMARK DATE. ADVISED CONSUMER THE PRODUCT BOX IS EXPIRED."