BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM-SINGLE PORT 20 GUAGE

    MDR report key: 20557700 · Received October 28, 2024

    Report

    Report Number
    MW5161731
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    September 26, 2024
    Report Date
    October 18, 2024
    Manufacturer
    BD / BECTON DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024 AT APPROXIMATELY 1300 HOURS, WHILE CONDUCTING AN INTRAVENOUS CATHETER INSERTION FOR PATIENT, THE ED (EMERGENCY DEPARTMENT) TECH HAD THE CATHETER MALFUNCTION DURING THE PROCEDURE. ED (EMERGENCY DEPARTMENT) TECH CHECKED THE IV PRIOR TO INSERTIONS AND DID NOT SEE ANY CONCERNS BEFORE ATTEMPTING TO PROCEED. HOWEVER, THE IV DID NOT MAKE IT A THIRD OF THE WAY IN THE VEIN (LOCATED AT THE LEFT ARM ANTECUBITAL VEIN) BEFORE THE CATHETER BENT AND BLOOD START TO POUR OUT OF THE SIDE OF THE CATHETER. ED TECH IMMEDIATELY REMOVED AND DRESS THE SITE WITH GAUZE. THE PATIENT DID NOT COMPLAIN OF PAIN OR DISCOMFORT. THE IV USED WAS 20 GAUGE BD NEXIVA CLOSED IV CATHETER SYSTEM-SINGLE PORT WITH LOT NUMBER 4030905 AND REFERENCE CODE 383517. BD NOTIFIED OF EVENT 9/27/24 AND ALL 20 GAUGE BD NEXIVA CLOSED IV CATHETER SYSTEM-SINGLE PORT WITH LOT NUMBER 4030905 AND REFERENCE CODE 383517 REMOVED FROM UNIT. PENDING RETURN PACKAGING FROM BD TO RETURN PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965483 BD NEXIVA CLOSED IV CATHETER SYSTEM-SINGLE PORT 20 GUAGE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BD / BECTON DICKINSON AND COMPANY 383517 4030905

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female