BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION PICC/CVL CAP

    MDR report key: 3121837 · Received May 15, 2013

    Report

    Report Number
    MW5030211
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 10, 2013
    Manufacturer
    CARE FUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A PICC LINE PLACED EARLIER IN THE DAY. AS THE RN DISCONNECTED AN IV INFUSION FROM ONE OF THE PICC LINE PORTS, BLOOD WAS NOTED FLOWING FROM THE LINE CAP. MINIMAL BLOOD LOSS WAS NOTED AS THE RN QUICKLY CLAMPED THE LINE AND REPLACED THE CAP. UPON FURTHER INSPECTION OF THE CAP INVOLVED, THE BLUE STOPPER WAS NOTED TO BE OFF CENTER ALLOWING FREE FLOW OF BLOOD. SINCE THE EQUIPMENT WAS PLACED IN RADIOLOGY, THE TECHNOLOGIST INVOLVED IN PLACEMENT WAS INTERVIEWED. HE STATED THIS TYPE OF PROBLEM, STOPPER LEAKAGE, OCCURS ROUTINELY AND THEY JUST DISCARDED THE PRODUCT AND GET ANOTHER. HE HAS NEVER REPORTED THIS PROBLEM TO HIS SUPERVISOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214998 CAREFUSION PICC/CVL CAP PICC/ CVL CAP FPA CARE FUSION 12108055

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR