BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 24945132 · Received April 21, 2026

    Report

    Report Number
    1710034-2026-00445
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 14, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835171
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 HUB WAS CRACKED AND LEAKED. ACCORDING TO THE CUSTOMER REPORT, THE CATHETER ADAPTER WAS CHIPPED. THE PATIENT WENT TO THE OPERATING ROOM WITH THE LINE SECURED FROM THE WARD. WHEN THE INFUSION LINE WAS CONNECTED, THE CATHETER ADAPTER WAS CHIPPED DURING USE. I WANT YOU TO INVESTIGATE WHETHER IT IS INSIDE OR OUTSIDE THE STANDARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998847 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown