BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3800642 · Received May 8, 2014

    Report

    Report Number
    1416980-2014-14832
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE CONDUCTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAVIA EMPTY CONTAINER BROKE DURING INFUSION OF CLINDAMYCIN. THE REPORTER STATED THAT THEY HAD BEEN RUNNING THE BAG AS A PIGGY BACK. THE NURSE STATED THAT THE PORT OF THE BAG BROKE AS IT WAS BEING DISCONNECTED FROM THE IV TUBING TO ATTACH A FLUSH BAG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279104 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR14A22097

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN IV TUBING