BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 4200805 · Received October 24, 2014

    Report

    Report Number
    1416980-2014-37355
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED DEVICE NOTED LOOSE PARTICULATE MATTER INSIDE THE MEMBRANE TUBE ASSEMBLY. THE CAUSE OR ORIGIN OF THE PARTICLE IS UNDETERMINED. A CAPA HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAVIA 150 ML BAG HAD A PARTICLE UNDER ITS BLUE PORT PROTECTOR TAB (COMPONENT THAT IS PULLED OFF BEFORE USE). THE PARTICLE WAS DESCRIBED AS A BLACK SPECK, APPROXIMATELY .25 INCHES LONG, WHICH APPEARED TO BE A THREAD. THIS WAS NOTICED WHEN THE EMPTY BAG WAS REMOVED FROM ITS OVERPOUCH AND BEFORE THE BAG WAS FILLED. THE REPORTER STATED THAT THERE WAS NO DAMAGE TO THE OVERPOUCH NOR TO THE BOX. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679738 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR12A28039

    Patients

    Seq Age Sex Outcome Treatment
    1