BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 1001325 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00160
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 27, 2008
    Report Date
    January 28, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K033892
    Removal / Correction Number
    Z-1116/1146-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THAT, WHEN SHE STARTED TO CHANGE HER CARTRIDGE AND INSULIN INFUSION SET TUBING LAST NIGHT, SHE NOTICED THE TUBING WAS SEPARATING FROM THE LUER LOCK CONNECTION. SHE STATED THIS HAS HAPPENED WITH 5 TUBINGS. SHE STATED SHE ONLY KEPT 1 OF THE BROKEN SETS. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS ULTRAFLEX 6J047UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP