BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTIV PLUS SAFETY IV CATHETER- RADIOPAQUE

    MDR report key: 2830263 · Received November 7, 2012

    Report

    Report Number
    MW5027559
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 26, 2012
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS TO HAVE A CARDIAC CATH; IV INSERTED IN THE ANTECUBITAL SPACE; WHEN DC'D A SMALL PART OF THE PLASTIC WAS LEFT IN. ULTRASOUND WAS PERFORMED AND PIECE NOT LOCATED. PHYSICIAN DECIDED TO NOT PURSUE AS IT WOULD CAUSE MORE DAMAGE THAN LEAVING THE PIECE IN. PT TO F/U WITH PHYSICIAN. UNABLE TO GET REP TO RETURN MY CALLS AFTER 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIV PLUS SAFETY IV CATHETER- RADIOPAQUE 22 G IV FOZ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other