BD SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC
Received Dec 6, 2021 · Event occurred Nov 8, 2021
Report 1920898-2021-01277 · MDR key 12940531
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
Bd Medical - Diabetes CareCatalog number
326894
Lot number
1084475
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE BD SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC HAD FOREIGN MATTER ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS "BROWN FOREIGN MATTER, SUSPECTED TAPE."
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST 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. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.