BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3081062 · Received April 26, 2013

    Report

    Report Number
    1416980-2013-10532
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    LHI
    PMA / PMN Number
    K973654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS VISUALLY INSPECTED, WITH NO ISSUES FOUND. A FUNCTIONAL TEST WAS PERFORMED BY ATTACHING THE DEVICE TO A VIAL AND A SOLUTION BAG. DURING THE TEST NO LEAKS WERE FOUND. THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED, NOR COULD A CAUSE BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    FACILITY REPORT NUMBER: (B)(4). COMPLAINT NO: (B)(4). THE MALFUNCTION WAS REPORTED TO HAVE HAPPENED ON AN UNKNOWN DAY IN (B)(6) 2013. 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 A VIAL MATE RECONSTITUTION DEVICE LEAKED. THE DEVICE LEAKED AFTER ACTIVATION BETWEEN THE VIAL AND THE ADAPTOR JUNCTION. THE MALFUNCTION RESULTED IN 5-10% OF THE DOSE BEING SPILLED. THIS MALFUNCTION OCCURRED BEFORE USE DURING RECONSTITUTION; THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181092 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - CLEVELAND GR12L20018

    Patients

    Seq Age Sex Outcome Treatment
    1