BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 1001350 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00123
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 01/30/08 THE PATIENT REPORTED THAT THE OUTER TUBING OF HIS INFUSION DEVICE "JUST STARTED TO DETACH" FROM THE LUER LOCK. HE STATED THAT THE INNER TUBING WAS STILL INTACT. HE STATED THAT HE CHECKS HIS INFUSION TUBING OFTEN. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE INFUSION TUBING HAD BEEN IN USE FOR 6 DAYS. HE STATED THAT HE NORMALLY CHANGES THE INFUSION TUBING EVERY 7 DAYS. HE WAS ADVISED TO CHANGE THE INFUSION TUBING EVERY 6 DAYS. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND 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 NA 7D124UF

    Patients

    Seq Age Sex Outcome Treatment
    1 NSULIN INFUSION PUMP| INSULIN