BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE CONSET

    MDR report key: 3599745 · Received December 4, 2013

    Report

    Report Number
    3003442380-2013-00011
    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

    IN NOVEMBER 2013, A VOLUNTARY PRODUCT RECALL FOR THE DEVICE WAS INITIATED AND REPORTED TO THE FDA UNDER REPORT #8021545-11/19/2013-0006. NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. NO RELEVANT TESTING COULD BE PERFORMED. IF LOT INFO WAS AVAILABLE, THE BATCH RECORDS AND THE COMPLAINT DATABASE WERE REVIEWED FOR RELEVANT DEVIATIONS AND SIMILAR COMPLAINTS. UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH (B)(4), THE DISTRIBUTOR OF THE INFUSION SET. THE INTERNAL REFERENCE NUMBER FOR THIS COMPLAINT AT (B)(4).

    Description of Event or Problem · 1

    TUBING SEPARATED FROM CONNECTOR DURING A TRAINING SESSION WITH CLINICAL MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629298 ASANTE CONSET ASANTE CONSET FPA UNOMEDICAL A/S PIDS FG #4226-5 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1