BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ANGIOCATH IV CATHETER

    MDR report key: 2931443 · Received January 17, 2013

    Report

    Report Number
    9610048-2013-00001
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    October 17, 2012
    Report Date
    January 16, 2013
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK AT THIS TIME WHETHER THE SAMPLE WILL BE RETURNED FOR EVAL. A PREPAID MAILING LABEL AND SHIPPING TUBE WERE SENT TO THE CUSTOMER FOR RETURN OF THE SAMPLE. SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER REGARDING THIS INCIDENT HAVE GONE UNANSWERED. IF ADDITIONAL INFO AND/OR A SAMPLE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INTERNAL FILE NUMBER: (B)(4). DATE SUBMITTED: (B)(4) 2013.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26456 BD ANGIOCATH IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other