BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H.10

    MDR report key: 9643210 · Received January 29, 2020

    Report

    Report Number
    1917413-2020-00048
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 9, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679220
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE BRAND NAME: BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES. INITIAL REPORTER PHONE #: UNKNOWN. PMA / 510(K)#: K945952 AND K901449. 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 · 1

    IT WAS REPORTED THAT THE LABELS WERE LIFTING OFF WITH A BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES. THIS OCCURRED WITH 40 TUBES PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPEN LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108554 SEE H.10 BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367922 9220487 50382903679220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other