BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1590708 · Received January 25, 2010

    Report

    Report Number
    8021545-2010-00002
    Event Type
    Malfunction
    Date Received
    January 25, 2010
    Date of Event
    July 29, 2009
    Report Date
    January 25, 2010
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K991759
    Removal / Correction Number
    Z-1705-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE USED DEVICE WAS RETURNED FOR EVAL. USED DEVICES: THE TUBING WAS VISUALLY INSPECTED FOR ANY TEARS OR CRACKS ON THE TUBING ITSELF AND ON THE ATTACHED CONNECTOR PARTS. FURTHERMORE, A FLOW TEST AND A P-CAP CONNECTOR VENT TEST WERE PERFORMED. THE MEMBRANE IN THE P-CAP CONNECTOR WAS HUMID AND THE SAMPLE ALSO FAILED THE P-CAP CONNECTOR VENT TEST. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR EVAL. REFERENCE SAMPLES: THE REFERENCE SAMPLES WERE TESTED AS THE RETURNED UNUSED SAMPLES. THE MEMBRANE IN THE P-CAP CONNECTOR WAS HUMID ON 1 OF THE RETAINED SAMPLES. THE SAMPLE ALSO FAILED THE P-CAP CONNECTOR VENT TEST. THE REMAINING 9 SAMPLES WERE IN ACCORDANCE WITH PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    NO INFO REGARDING INCIDENT WAS MADE AVAILABLE TO UNOMEDICAL A/S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FPA UNOMEDICAL A/S MMT-399 8200795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA