BD¿ ALCOHOL SWABS
Received Aug 16, 2023 · Event occurred Jul 27, 2023
Report 1920898-2023-00565 · MDR key 17557344
Device
Product problems
- Missing Information
- Missing Information
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) 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. 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 BOX OF BD¿ ALCOHOL SWABS HAD NO EXPIRATION DATE LISTED ON THE BOX OR PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND BOX IN HOUSE - NO EXPERATION DATE ON BOX OR PACKAGE. WITH REVIEW OF LOT NUMBER THINKING BOX IS EXPIRED YEAR 2021. INFORMED CALLER EXPIRED AND SHOULD BE DISCARDED."