BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA

    MDR report key: 5885293 · Received August 18, 2016

    Report

    Report Number
    5885293
    Event Type
    Malfunction
    Date Received
    August 18, 2016
    Date of Event
    August 3, 2016
    Report Date
    August 6, 2016
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MANAGER IN AN AMBULATORY SETTING REPORTED THAT AFTER PLACING AN IV IN A PATIENT WITH AN AVF (ARTERIOVENOUS) FISTULA WITH A #20 GAUGE IV (BD-SAF-T-INTIMA, LOT #5240864), THE IV WAS LEAKING. AFTER THE IV WAS PLACED, BLOOD WAS NOTED TO BE LEAKING OUT OF THE TUBING. THE MANAGER SUSPECTED A HOLE IN THE CATHETER TUBING. THE IV WAS REMOVED AND A NEW #20 GAUGE IV WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539453 BD SAF-T-INTIMA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BD 5240864

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER DEVICE USED