SWAB ALCOHOL
Received Aug 27, 2021 · Event occurred Jul 29, 2021
Report 1920898-2021-00939 · MDR key 12380505
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 MANUFACTURING RECORDS WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR MISSING LABEL INFORMATION (EXPIRATION DATE/PACKET) ON LOT # 1256143. 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 - DUE TO THE BATCH BEING MANUFACTURED IN 2011 AND FILES ARE RETAINED FOR 7 YEARS NO DHR REVIEW CAN BE COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT 3 SWAB ALCOHOL UNITS HAD LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED 2 BOXES WITH THE SAME LOT # MISSING THE EXPIRY DATE ON THE BOXES AND PACKETS OR PADS. DATE OF EVENT : (B)(6) 2021. SAMPLE : NO.