BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM-DUAL PORT

    MDR report key: 8912657 · Received August 19, 2019

    Report

    Report Number
    MW5089197
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 14, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT FAILURE 18G PIV LOT 9029871. PIV ACCESS STARTED, DURING BLOOD DRAW AIR BEGAN COMING THROUGH TUBING, PIV FLUSHED TO DETERMINE PATENCY AND AIR BUBBLING NOTED AT ANGIOCATH AND FIRST JUNCTION. PIV DISCOUNTED AND PIV HAD TO BE RESTARTED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698823 BD NEXIVA CLOSED IV CATHETER SYSTEM-DUAL PORT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BD 9029871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other