SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC
Received Dec 28, 2020 · Event occurred Nov 24, 2020
Report 1920898-2020-01761 · MDR key 11083449
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
Bd Medical - Diabetes CareCatalog number
326894
Lot number
0163467
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
H.6. INVESTIGATION: CUSTOMER RETURNED (4) BD ALCOHOL SWABS (3 LOOSE, 1 SEALED) FROM LOT # 0163467. CUSTOMER STATES THAT THERE IS FOREIGN MATTER. THE RETURNED SWABS WERE EXAMINED AND 2 OUT OF 4 SWABS EXHIBITED SPLICING TAPE ON THE SWAB PAD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0163467. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE: ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.
Description of Event or Problem
IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC HAD FOREIGN MATTER ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER.
Additional Manufacturer Narrative
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC HAD FOREIGN MATTER ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER.