BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25191378 · Received May 15, 2026

    Report

    Report Number
    1710034-2026-00526
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 CATHETER LEAKED. KINK IN THE CANNULA WAS NOTICED (NEAR THE PORT) AFTER INSERTION AND BLOOD DRIPPED FROM THAT AREA WHEN DID THE INCIDENT OCCUR? DURING USE IT WAS REPORTED THAT THE KINK IN THE CANNULA WAS NOTICED (NEAR THE PORT) AFTER INSERTION AND BLOOD DRIPPED FROM THAT AREA, IT WAS DEEMED UNSUITABLE TO DELIVER CONTRAST VIA INJECTION PUMP. CANNULA WAS REDONE. I HAVE CHECKED WITH ALL STAFF PRESENT, CANNULA WASN'T PULLED OR ANY VARIATION IN TECHNIQUE FROM THE STAFF MEMBER. 5/5/2026 ADDITIONAL INFORMATION: WAS THERE ANY PATIENT IMPACT. THE PATIENT NEEDED TO BE RE-CANULATED. UNNECESSARY PROCEDURE DUE TO PRODUCT FAILURE. WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? IF YES, PLEASE EXPLAIN ¿ NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429678 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5294966 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1