BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ALCOHOL SWABS

    MDR report key: 13179081 · Received January 6, 2022

    Report

    Report Number
    1920898-2021-01375
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 8, 2021
    Report Date
    February 16, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    LKB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED 2 OPENED AND 20 UNOPENED ALCOHOL SWAB PACKETS FROM LOT 1221802. THE 2 OPENED ALCOHOL SWAB PACKETS FEATURE ALCOHOL SWABS WITH SIGNIFICANT YELLOWISH DISCOLORATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #1221802. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF SWAB DISCOLORATION. ROOT-CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED BD¿ ALCOHOL SWABS HAD FOREIGN MATERIAL ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE ALCOHOL SWABS ARE DISCOLORED, SHOWING A YELLOWISH COLOR."

    Description of Event or Problem · 0

    IT WAS REPORTED BD¿ ALCOHOL SWABS HAD FOREIGN MATERIAL ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE ALCOHOL SWABS ARE DISCOLORED, SHOWING A YELLOWISH COLOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30998 BD¿ ALCOHOL SWABS PAD, ALCOHOL, DEVICE DISINFECTANT LKB BD MEDICAL - DIABETES CARE 1221802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown