BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD LATEX FREE PRIMARY IV SET

    MDR report key: 1770071 · Received July 1, 2010

    Report

    Report Number
    1770071
    Event Type
    Malfunction
    Date Received
    July 1, 2010
    Date of Event
    June 20, 2010
    Report Date
    July 1, 2010
    Manufacturer
    HOSPIRA INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    NURSE WAS UNABLE TO GET PRIMARY IV SET TO PRIME. EXAMINATION REVEALED PRESENCE OF MULTIPLE (17) KINKS IN THE TUBING.NURSE OBTAINED ANOTHER SET (SAME CATALOGUE #) FROM SHELF AND WAS ABLE TO PRIME SET. MANUFACTURER HAS BEEN INFORMED OF PROBLEM AND HAS REQUESTED RETURN OF DEFECTIVE SET.THIS REPORT IS MADE DUE TO THE POTENTIAL FOR HARM TO PATIENT IF DRUG THERAPY SHOULD BE DELAYED DURING MEDICAL EMERGENCY AS A RESULT OF KINKS IN AN IV TUBING SET.====================== HEALTH PROFESSIONAL'S IMPRESSION======================CARELESSNESS IN MANUFACTURING / PACKAGING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD LATEX FREE PRIMARY IV SET IV TUBING SET FPA HOSPIRA INC * UNNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *