BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC CLEAR

    MDR report key: 2073537 · Received April 14, 2011

    Report

    Report Number
    2073537
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BARD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE INTRODUCED THE BARD POWERLOC CLEAR NEEDLES TO OUR HOSPITAL TWO MONTHS AGO. IT WAS REPORTED THAT A PATIENT WITH A DOUBLE LUMEN PORT HAD SOME MINIMAL LEAKING FROM THE OUTER LUMEN. THE INNER LUMEN HAD CHEMOTHERAPY INFUSING, AND THE LINE THAT WAS LEAKING HAD SALINE. THE NURSE REPORTED THAT THE LEAK SEEMED TO BE COMING FROM THE IV TUBING OR THE CLAVE AND THE PLASTIC POWERLOC CONNECTOR APPEARED TO BE CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLOC CLEAR INTRAVASCULAR TUBING FPA BARD * ASTD S034
    2 CLAVE INTRAVASCULAR TUBING, CONNECTOR FPA ICU MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * CHEMOTHERAPY