SWAB ALCOHOL 100 BX 1200
Received Mar 7, 2021 · Event occurred Feb 8, 2021
Report 1920898-2021-00274 · MDR key 11427167
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
Bd Medical - Diabetes CareCatalog number
326895
Lot number
SEE H.10.
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0226909. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.
Description of Event or Problem
IT WAS REPORTED THAT 3 SWAB ALCOHOL 100 BX 1200 HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT TWO SWABS WERE YELLOW ON THE EDGE FROM ONE BOX AND ONE SWAB FROM THE OTHER BOX.. VERBATIM: CONSUMER REPORTED FOUND WITH 2 SWABS FM - 1/4" YELLOW ON THE EDGE OF SWABSLOT # 0226909. CATALOG# 326895. DATE OF EVENT: UNKNOWN. SAMPLE STATUS AWAITING SAMPLE CONSUMER REPORTED 1/4" YELLOW ON THE EDGE OF SWABSLOT # UNKNOWN. CATALOG# 326895. DATE OF EVENT :UNKNOWN. SAMPLE STATUS DISCARDED."
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0226909. MEDICAL DEVICE EXPIRATION DATE: 2025-07-31. DEVICE MANUFACTURE DATE: 2020-08-13. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT 3 SWAB ALCOHOL 100 BX 1200 HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT TWO SWABS WERE YELLOW ON THE EDGE FROM ONE BOX AND ONE SWAB FROM THE OTHER BOX. VERBATIM: CONSUMER REPORTED FOUND WITH 2 SWABS FM - 1/4" YELLOW ON THE EDGE OF SWABS: LOT # 0226909, CATALOG# 326895, DATE OF EVENT: UNKNOWN. SAMPLE STATUS: AWAITING SAMPLE. CONSUMER REPORTED 1/4" YELLOW ON THE EDGE OF SWABS: LOT # UNKNOWN, CATALOG# 326895, DATE OF EVENT: UNKNOWN. SAMPLE STATUS: DISCARD".