BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 10796396 · Received November 5, 2020

    Report

    Report Number
    1710034-2020-00711
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 14, 2020
    Report Date
    December 1, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835110
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED A BROKEN CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383511 BATCH NO: UNKNOWN COMPLAINT 2 OF 2 THIS IS THE SECOND EVENT FOR THE SAME PRODUCT CATALOGUE IN THE SAME DEPARTMENT NEXIVA 24G SINGLE PORT 383511 INCIDENT HAPPEN ON: (B)(6) 2020. INCIDENT: CATHETER BREAKAGE FAILURE DURING INSERTION NO ONE WAS ARM AND OTHER PIV WAS INSERTED.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED A BROKEN CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383511 BATCH NO: UNKNOWN. COMPLAINT 2 OF 2. THIS IS THE SECOND EVENT FOR THE SAME PRODUCT CATALOGUE IN THE SAME DEPARTMENT. NEXIVA 24G SINGLE PORT 383511. INCIDENT HAPPEN ON: OCTOBER 14. INCIDENT: CATHETER BREAKAGE FAILURE DURING INSERTION. NO ONE WAS ARM AND OTHER PIV WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254839 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383511 UNKNOWN 30382903835110

    Patients

    Seq Age Sex Outcome Treatment
    1