SWAB ALCOHOL 100 BX 1200
Received Nov 17, 2020 · Event occurred Oct 23, 2020
Report 1920898-2020-01579 · MDR key 10849722
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
Bd Medical - Diabetes CareCatalog number
326895
Lot number
UNKNOWN
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 WAS MISSING THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 326895 BATCH NO: 3206178. IT WAS REPORTED THAT THE CONSUMER WANTED TO KNOW THE EXPIRATION DATE ON THE BOX.
Additional Manufacturer Narrative
H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DUE TO THIS BATCH BEING MANUFACTURED IN (B)(4), FILES ARE RETAINED FOR 7 YEARS, NO DHR REVIEW CAN BE COMPLETED.
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 3206178. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6), USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 WAS MISSING THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 326895, BATCH NO: 3206178. IT WAS REPORTED THAT THE CONSUMER WANTED TO KNOW THE EXPIRATION DATE ON THE BOX.