BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA MAXZERO

    MDR report key: 24913801 · Received April 17, 2026

    Report

    Report Number
    1710034-2026-00429
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 6, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835515
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K183399; K243403. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING HAD A HOLE. INJURIES OR ADVERSE EVENT: YES REPORTED ISSUE: 24 G PIV MALFUNCTIONED DURING A PIV PLACEMENT ON 3 Y/O PATIENT REQUIRING NEED FOR ADDITIONAL IV ACCESS D/T DEVICE MALFUNCTION. ADDITIONAL INFORMATION 4/6/2026 CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? DATE OF EVENT: 3/24/2026 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE NOTED. ADDITIONAL INFORMATION 4/10/2026: IT IS STATED THAT " 24 G PIV MALFUNCTIONED DURING A PIV PLACEMENT ON 3 Y/O PATIENT REQUIRING NEED FOR ADDITIONAL IV ACCESS D/T DEVICE MALFUNCTION." PLEASE DESCRIBE THE "MALFUNCTION. "TUBING FROM PIV DEVICE TO EXTENSION CONNECTION HAD A HOLE, SO WHEN WE CHECKED FOR PATENCY THERE WAS LEAKING FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970463 NEXIVA MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown