BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPIRA

    MDR report key: 2132665 · Received June 10, 2011

    Report

    Report Number
    MW5020991
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSPIRA VENTED TUBING CAME APART AT THE CLAVE DUE TO A DEFECT IN THE TUBING. PT WAS RECEIVING PROPOFOL INFUSION WHEN A PUDDLE OF PROPOFOL WAS NOTED BENEATH PT'S BED. IV TUBING FOR PROPOFOL HAD COME APART FROM ITSELF AND WAS LEAKING ONTO FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA PRIMARY SYMBIQ SET WITH 2 CLAVES LIST NUMBER 16019-01 FRN HOSPIRA DON'T HAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR