BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    133 INCH X 17.2, 60 DROP PRIMARY, 2 BRAVO24, 2 102, 24 HR USE ONLY

    MDR report key: 5722882 · Received June 8, 2016

    Report

    Report Number
    MW5062802
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    June 8, 2016
    Report Date
    June 8, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STERILE 60 DROP PRIMARY IV TUBING REF # (B)(4) FROM ICU MEDICAL, INC., WAS FOUND TO HAVE A LARGE 15MM LENGTH BY 3MM WIDTH HOLE. LOT # 3173028, EXP: (B)(6) 2021, APPROX 240MM BELOW UPPER INJECTION HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362458 133 INCH X 17.2, 60 DROP PRIMARY, 2 BRAVO24, 2 102, 24 HR USE ONLY PRIMARY IV TUBING LHI ICU MEDICAL, INC. 3173028

    Patients

    Seq Age Sex Outcome Treatment
    1