BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3122876 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13064
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY BAXTER; HOWEVER, THE DEVICE EVALUATION IS NOT YET COMPLETE. THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. ONE DEVICE WAS RECEIVED FOR EVALUATION AGAINST THE REPORTED CONDITION. THE INITIAL VISUAL INSPECTION REVEALED THAT THERE WAS INDEED A CUT IN THE MEMBRANE TUBE ASSEMBLY. ADDITIONAL PRESSURE TESTING WAS PERFORMED AND THE DEVICE FAILED THIS TEST, CONFIRMING THE REPORTED CONDITION OF A LEAKING DEVICE. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOLE WAS DETECTED IN THE ADMINISTRATION PORT OF AN INTRAVIA EMPTY CONTAINER. THE DEVICE WAS FILLED VIA THE MEDICATION PORT WITH 2 ML/MG HYDROMORPHONE USING A NON-BAXTER PUMP AND NEEDLE AND SHIPPED TO THE CUSTOMER. THE CUSTOMER REPORTED THAT THE BAG LEAKED FROM A HOLE DETECTED IN THE ADMINISTRATION PORT WHEN THE BLUE PROTECTIVE PORT COVER WAS REMOVED DURING SETUP. NO PATIENT INVOLVEMENT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224348 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR12K05193

    Patients

    Seq Age Sex Outcome Treatment
    1