BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC

    MDR report key: 11083449 · Received December 28, 2020

    Report

    Report Number
    1920898-2020-01761
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    November 24, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    LKB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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 · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548214 SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC PAD, ALCOHOL, DEVICE DISINFECTANT LKB BD MEDICAL - DIABETES CARE 0163467

    Patients

    Seq Age Sex Outcome Treatment
    1