BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1082385 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01110
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    April 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT'S FATHER REPORTED THAT THE PATIENT'S INFUSION SETS HAVE BEEN CRACKING AT THE LUER LOCK. THIS HAS HAPPENED WITH TWO LOTS OF INFUSION SETS. HE WAS ADVISED TO INSTRUCT THE PATIENT NOT TO OVER-TIGHTEN THE LUER CONNECTION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FOZ DISETRONIC MEDICAL SYSTEMS NA 526711

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP