BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIT-SIPHON PCA EXTENSION SET

    MDR report key: 3070388 · Received April 12, 2013

    Report

    Report Number
    3070388
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    RN DISCONNECTING TUBING SET TO CHANGE MEDICATION AND CONNECTOR BROKE. NO FORCE WAS USED TO DISCONNECT.MANUFACTURER RESPONSE FOR ANIT-SIPHON PCA EXTENSION SET, (BRAND NOT PROVIDED) (PER SITE REPORTER).THEY TOOK DOWN A DESCRIPTION OF THE INCIDENT, ISSUED REPORT# AND ARE SENDING A RETURN KIT. THEY WILL ADVISE OF THEIR FINDING AFTER PRODUCT HAS BEEN EVALUATED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158887 ANIT-SIPHON PCA EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *