BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1021833 · Received March 28, 2008

    Report

    Report Number
    2183996-2008-00413
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 9, 2008
    Report Date
    March 19, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT'S MOTHER REPORTED THAT "SOMETIME LAST WEEK" THE CANNULA OF THE PT'S INFUSION SITE WAS SLIGHTLY BENT WHEN IT WAS REMOVED FROM HER ABDOMEN. SHE STATED THAT THIS HAS OCCURRED ON TWO OCCASIONS. BOTH INFUSION SITES WERE DISCARDED. NO PHYSIOLOGICAL EFFECT WAS REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PROD WILL BE RETURNED FOR EVAL.

    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 589724

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP