BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

    MDR report key: 7669633 · Received July 9, 2018

    Report

    Report Number
    3002807615-2018-00001
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Date of Event
    June 7, 2018
    Report Date
    July 6, 2018
    Manufacturer
    TEVA MEDICAL LTD., MIGADA SITE
    Product Code
    ONB
    PMA / PMN Number
    K141448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    [(B)(4)].

    Description of Event or Problem · 1

    UPON COMPLETION OF THE INVESTIGATION, NO LINK WAS OBSERVED TO ANY PARTICULATE MATTER, AS DESCRIBED IN THE VERBAL COMPLAINT, IN THE DRIP CHAMBER AT THE COMPLETION OF THE DRUG INFUSION WHILE USING TEVADAPTOR WITH AN INFUSION OF INTERLEUKIN BY PROMETHEUS. AS PART OF THE INVESTIGATION, THE LEAFLET OF INTERLEUKIN II ("PROLEUKIN" OF "PROMETHEUS") WAS EXAMINED AND THE FOLLOWING WARNING WAS FOUND: "IN-LINE FILTERS SHOULD NOT BE USED WHEN ADMINISTERING PROLEUKIN". THE TEVADAPTOR DOES HAVE AN IN-LINE FILTER. THEREFORE, THE CONCLUSION IS THAT THE INCIDENT OCCURRED DUE TO IMPROPER USE. FOR COMPLETE DETAILS REFER TO THE (B)(4) COMPLAINT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513875 TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB TEVA MEDICAL LTD., MIGADA SITE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other