BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 1001313 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00152
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE EXPERIENCED AN E4 (OCCLUSION) ON HER INFUSION DEVICE. TO TROUBLESHOOT SHE WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE AND TO BOLUS THROUGH THE INFUSION TUBING. THE E4 RECURRED. SHE THEN REMOVED HER INFUSION SITE AND STATED IT WAS BENT AT AN ANGLE AND THE SITE BLED WHEN IT WAS REMOVED. SHE STATED, THE INFUSION SITE MAY HAVE BEEN IN USE FOR 4 DAYS. SHE WAS ADVISED TO CHANGE THE INFUSION SITE EVERY 3 DAYS. SHE WAS ADVISED TO CHANGE INSULIN CARTRIDGE, INFUSION TUBING, AND INFUSION SITE. SHE WAS ABLE TO PRIME THE INFUSION TUBING WITHOUT ERROR. SHE ALSO STATED THAT THE EDGES OF THE ADHESIVE OF THE INFUSION SITE WERE "PEELING" UP. SHE STATED THAT SHE HAS DIFFICULTY KEEPING THE ADHESIVE STUCK TO HER SKIN. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 NA 7J201UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN