BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALCOHOL SWABS

    MDR report key: 17692738 · Received September 6, 2023

    Report

    Report Number
    1920898-2023-00599
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 21, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: 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# 3082127. ALL INSPECTION PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALCOHOL SWABS HAD FOREIGN MATTER. VERBATIM: CONSUMER REPORTED SHE IS FINDING SWABS THAT ARE "PINK AND PURPLE" PRIOR TO USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALCOHOL SWABS HAD FOREIGN MATTER. VERBATIM: CONSUMER REPORTED SHE IS FINDING SWABS THAT ARE "PINK AND PURPLE" PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224176 BD ALCOHOL SWABS HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 3082127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown