BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.00IN HF Y

    MDR report key: 11618309 · Received April 6, 2021

    Report

    Report Number
    1710034-2021-00277
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 10, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS EVENT BUT WITHOUT A SAMPLE NO CORRECTIVE ACTIONS COULD BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 20GA 1.00IN HF Y WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383536. BATCH NO.: UNKNOWN. IT WAS REPORTED THERE WAS A HOLE OR CRACK IN THE CATHETER THAT CAUSED LEAKAGE DURING IV PLACEMENT. WHILE PLACING NEXIVA, APPEARED TO BE A HOLE/CRACK HALF WAY UP CATHETER. WHILE ADVANCING CATHETER INTO VEIN, BLOOD STARTED COMING THE MIDDLE OF THE IV.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEXIVA 20GA 1.00IN HF Y WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383536, BATCH NO.: UNKNOWN. IT WAS REPORTED THERE WAS A HOLE OR CRACK IN THE CATHETER THAT CAUSED LEAKAGE DURING IV PLACEMENT. WHILE PLACING NEXIVA, APPEARED TO BE A HOLE/CRACK HALF WAY UP CATHETER. WHILE ADVANCING CATHETER INTO VEIN, BLOOD STARTED COMING THE MIDDLE OF THE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517183 NEXIVA 20GA 1.00IN HF Y INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1