BD¿ ALCOHOL SWABS
Received Jun 13, 2023 · Event occurred May 22, 2023
Report 1920898-2023-00356 · MDR key 17122226
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
Bd Medical - Diabetes CareCatalog number
326895
Lot number
2332313
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
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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #2332313. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS.
Description of Event or Problem
IT WAS REPORTED THAT THE BD¿ ALCOHOL SWABS EXPERIENCED FOREIGN MATTER, CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, THERE IS A "BROWNISH COLOR" ON SWABS BEFORE USE.
Description of Event or Problem
IT WAS REPORTED THAT THE BD¿ ALCOHOL SWABS EXPERIENCED FOREIGN MATTER, CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, THERE IS A "BROWNISH COLOR" ON SWABS BEFORE USE.
Additional Manufacturer Narrative
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.