BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE COMFORT

    MDR report key: 3599744 · Received December 4, 2013

    Report

    Report Number
    8021545-2013-00011
    Event Type
    Malfunction
    Date Received
    December 4, 2013
    Date of Event
    September 10, 2013
    Report Date
    November 29, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K120872
    Removal / Correction Number
    8021545-11/19/2013-0006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR REPORT HAS BEEN MADE SINCE THIS EVENT HAS LED TO A RECALL. THIS INCIDENT HAS ALREADY BEEN REPORTED TO THE FDA IN THE ASR REPORT FOR Q3 2013. IN NOVEMBER 2013, A VOLUNTARY PRODUCT RECALL FOR THE DEVICE WAS INITIATED AND REPORTED TO THE FDA UNDER REPORT #8021545-11/19/2013-0006. (B)(4). A VISUAL INSPECTION AND A TEST FOR FLOW WERE PERFORMED ON THE RETURNED USED DEVICE. IN THE VISUAL INSPECTION, THE TUBING WAS DETACHED FROM THE TUBING-ASANTE CONNECTOR. THE FLOW TEST WAS IN ACCORDANCE WITH SPECS. THE LEAK AND STATIC PULL OF THE TUBING-ASANTE CONNECTOR CANNOT BE PERFORMED DUE TO THE CONDITION OF THE SAMPLE. NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH (B)(4), THE DISTRIBUTER OF THE INFUSION SET. (B)(4).

    Description of Event or Problem · 1

    PT'S TUBING DISCONNECTED FROM TUBING CONNECTOR. TUBING ALSO HAD A DIFFERENT GREY COLOR PT OBSERVED. PT DID NOT REPORT A HYPERGLYCEMIA EVENT. COMFORT 43 INCH 13MM. PT HAS SEVERAL BOXES OF INFUSION SETS, SO WASN'T SURE WHICH ONE IT CAME FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629796 ASANTE COMFORT ASANTE COMFORT FPA UNOMEDICAL A/S 4143-5 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1