BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 6208399 · Received December 28, 2016

    Report

    Report Number
    6208399
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    November 9, 2016
    Report Date
    December 6, 2016
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTRAVENOUS CATHETER WAS FOUND TO NOT SEPARATE FROM THE HUB AS IT SHOULD BEFORE INSERTION. UPON FURTHER INSPECTION, AN AREA ON THE SIDE OF THE HUB APPEARED TO EITHER HAVE A MELTED SPOT OF PLASTIC OR GLUE. MANUFACTURER RESPONSE FOR IV CATHETER, BD NEXIVA 20GA1.00IN (PER SITE REPORTER): EQUIPMENT FAILURE COMMUNICATED WITH BD QUALITY SYSTEMS SPECIALIST. ARRANGEMENTS MADE TO SEND INVOLVED EQUIPMENT TO MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859757 NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BD 6148692

    Patients

    Seq Age Sex Outcome Treatment
    1