BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SECONDARY SET

    MDR report key: 3076666 · Received April 18, 2013

    Report

    Report Number
    3076666
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    RN TRIED TO UNSCREW SECONDARY TUBING FROM PRIMARY FLUSH SET AND THE TIP OF THE CAP FROM THE SECONDARY SET BROKE OFF IN THE PRIMARY SET AND THE NORMAL SALINE FLUID IN THE BAG STARTED GUSHING OUT. ENTIRE PRIMARY AND SECONDARY SET DETACHED FROM PATIENT WITH NO MEDICATIONS LOST. DEFECTIVE TUBING PLACED IN BIOHAZARD BAG AND GIVEN TO CLINICAL LEADER. DO NOT HAVE ORIGINAL PACKAGING FOR LOT AND/OR SERIAL NUMBER. NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REMOVING SECONDARY SET FROM MAIN SET.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167900 UNIVERSAL SECONDARY SET SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION * *
    168284 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION 43.7600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR