SWAB ALCOHOL
Received Sep 3, 2021 · Event occurred Aug 5, 2021
Report 1920898-2021-00963 · MDR key 12425986
Device
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDICAL DEVICE EXPIRATION DATE : NA. INVESTIGATION SUMMARY : EXEC SUMMARY - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR MISSING LABEL INFORMATION (EXPIRATION DATE/PACKET) ON LOT # 5139929. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CAPA/SA - BASED ON THE ABOVE NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.
Description of Event or Problem
IT WAS REPORTED THAT 1 SWAB ALCOHOL UNIT HAD LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED AN UNOPENED BOX OF SWABS THAT DID NOT CONTAIN A EXPIRATION DATE. DATE OF EVENT : (B)(6) 2021. SAMPLE STATUS : DISCARDED.