BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEHP-FREE GRAVITY 15M FLT 200CM

    MDR report key: 10609476 · Received September 30, 2020

    Report

    Report Number
    2243072-2020-01534
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 4, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LISTED IS NOT A FINISHED MEDICAL DEVICE BY BD AND THEREFORE SHOULD NOT HAVE BEEN REPORTED. MFR# 2243072-2020-01534 IS CANCELLED AND VOID AS A RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEHP-FREE GRAVITY 15¿M FLT 200CM WAS MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LABEL WITH LOT INFORMATION OR EXPIRATION DATE ON THE BLISTER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CAREFUSION MFR PLANT NUMBER HAS NOT BEEN PUT IN THE GLOBAL TRACKWISE SYSTEM YET. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4). 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 DEHP-FREE GRAVITY 15M FLT 200CM WAS MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LABEL WITH LOT INFORMATION OR EXPIRATION DATE ON THE BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070987 DEHP-FREE GRAVITY 15M FLT 200CM INTRAVASCULAR ADMINSTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other