BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PRIMARY IV TUBING

    MDR report key: 2958526 · Received January 11, 2013

    Report

    Report Number
    9616066-2013-00021
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS SET WAS DISCARDED. THE CUSTOMER COMPLAINT OF SET LEAKED DUE TO A PIN HOLE AND THE END OF THE IV SET BROKE OFF INSIDE THE HUB OF THE PICC COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FLUID LEAKED FROM A PINHOLE APPROXIMATELY 4 FEET DOWN FROM THE TOP OF THE IV SET AND THE END OF THE IV SET BROKE OFF INSIDE THE HUB OF THE PICC. REPORTED D51/2NS WITH 20 MEQ KCL WAS INFUSING AT 84 ML/HR AT THE TIME THE LEAK WAS NOTED, UNK HOW LONG THE SET HAD BEEN IN USE. EVENT OCCURRED IN 8NORTH, ENT/PLASTICS UNIT. THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PT INFORMATION PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17301 ALARIS PRIMARY IV TUBING FPA CAREFUSION CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PICC LINE, MANUFACTURER/LOT # UNK