BD¿ ALCOHOL SWABS
Received Jul 6, 2022 · Event occurred Jun 6, 2022
Report 1920898-2022-00427 · MDR key 14930852
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
Bd Medical - Diabetes CareCatalog number
326895
Lot number
4315755
Product problems
- Missing Information
- Missing Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, (B)(6) WAS USED AS A PLACE HOLDER.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD¿ ALCOHOL SWABS THAT THERE IS NO EXPIRATION DATE ON SHELF CARTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED SHE DOES NOT SEE AN EXPIRATION DATE AND ASKED IF ALCOHOL SWABS EXPIRED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD¿ ALCOHOL SWABS THAT THERE IS NO EXPIRATION DATE ON SHELF CARTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED SHE DOES NOT SEE AN EXPIRATION DATE AND ASKED IF ALCOHOL SWABS EXPIRED.
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST RELATED COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.