BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER

    MDR report key: 5463536 · Received February 26, 2016

    Report

    Report Number
    3007966929-2016-00007
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Date of Event
    February 2, 2016
    Report Date
    February 2, 2016
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    FFD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HEIGHT: 160 FEET. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO LOT NUMBER OR PRODUCT EVALUATION SAMPLE IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER, NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON FEBRUARY 26, 2016 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPACE OF THE SAMPLING PORT IS BLOCKED WITH URINE SEDIMENT AND IT IS DIFFICULT TO TAKE THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119418 UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER DEVICE, URINE FLOW RATE MEASURING FFD UNOMEDICAL LTD. 158100140190

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR