SWAB ALCOHOL 100 BX 1200

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: LEVEL B INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR MISSING LABEL CONTENT (EXPIRATION DATE) DUE TO UNKNOWN LOT NUMBER. 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) WAS NOT CAPTURED ON THIS DOCUMENT. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR CHECK FOR MISSING LABEL CONTENT (EXPIRATION DATE) DUE TO UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. 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 SWAB ALCOHOL 100 BX 1200 WAS MISSING THE EXPIRATION DATE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 326895; BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE CONSUMER FOUND PRODUCT IN HER HOME THAT WAS WITHOUT THE EXPIRATION DATE. THE BD ALCOHOL SWABS AND KNOWS THEY WERE PURCHASED IN 2008 AND ASKED IF SHE COULD STILL USE THEM. VERBATIM: FROM PHONE CALL ON (B)(6) 2020 11:36:59: CONSUMER REPORTED HAD FOUND PRODUCT IN HER HOME THAT WAS WITHOUT EXP DATES. THE BD ALCOHOL SWABS 326895 KNOWS THEY WERE PURCHASED IN 2008 ASKING IF SHE CAN STILL USE. ADVISED BD TEST PRODUCTS FOR USABILITY UP TO 5 YEARS. INFORMED WOULD NOT BE ABLE TO SPEAK ON ITS BEHALF. SHE REPLIED OK I'M NOT USING THEM ON MY VIAL JUST USING FOR CLEANING MY HANDS WHEN I'M OUT. DUE TO PANDEMIC. -- CONSUMER IS USING THIS EXPIRED PRODUCT FOR CLEANING ONLY FOR PANDEMIC NOT INJECTIONS.