BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVIA CONTAINER EMPTY

    MDR report key: 5993490 · Received October 3, 2016

    Report

    Report Number
    1416980-2016-15858
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 21, 2017
    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

    THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL LEAK AND PRESSURE TESTING WAS PERFORMED AND THE DEVICE LEAKED BETWEEN THE PORT TUBE AND THE PORT SEAL AREA. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS 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

    DEVICE MANUFACTURER ADDRESS 2: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A INTRAVIA CONTAINER WAS LEAKING AT THE SEAM OF THE SPIKE PORT. THE DEVICE WAS FILLED WITH HYDROMORPHONE AND BUPIVACAINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645849 INTRAVIA CONTAINER EMPTY CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO NA UR15L16070

    Patients

    Seq Age Sex Outcome Treatment
    1