BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOCATH

    MDR report key: 2871336 · Received October 23, 2012

    Report

    Report Number
    2871336
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANGIOCATH WAS IN LEFT RADIAL ARTERY AND WAS BEING REMOVED BY ICU NURSE. UPON INSPECTION OF CATHETER AFTER REMOVAL, NURSE NOTED THAT ALL OF THE CATHETER WAS NOT INTACT, AS ABOUT 2 CM OF IT HAD BROKEN OFF. PATIENT TAKEN TO SURGERY THE NEXT DAY BY VASCULAR SURGEON TO REMOVE CATHETER, BUT IT MIGRATED TO THE HAND, SO IT WAS NOT REMOVED; ARTERIOGRAM SHOWED GOOD COLLATERAL FLOW AND A PATENT RADIAL ARTERY. SURGEON TO INTERVENE FURTHER IF ISCHEMIA OF FINGERS DEVELOPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOCATH IV CATHETER FOZ BD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR