BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPIRA LIFESHIELD

    MDR report key: 1970113 · Received January 19, 2011

    Report

    Report Number
    MW5019098
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 19, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BUFF CAP ON BURETTE PLUMSET IV TUBING BROKE OFF ON 2 SEPARATE DEVICES. OBSTETRICS DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA LIFESHIELD BURETTE PLUMSET 150ML, 124 IN, LATEX-FREE FPA HOSPIRA 19231-12

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA