BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 6324024 · Received February 10, 2017

    Report

    Report Number
    3007966929-2017-00003
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Report Date
    January 17, 2017
    Product Code
    FFG
    PMA / PMN Number
    UNK
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: UNOMETER SAFETI. COMMON NAME: DEVICE URINE FLOW RATE MEASURING, NON ELECTRICAL. PROCODE: (FFG). (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A PRODUCT MALFUNCTION. NO PATIENT HARM WAS REPORTED. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW WAS PERFORMED. A PREVIOUS NON-CONFORMANCE IS ASSOCIATED WITH THIS COMPLAINT, WHICH IS CLOSED. THE INVESTIGATION CONCLUDES THE LIKELY ROOT CAUSE FOR THE ISSUE ¿STOP FLOW BETWEEN PATIENT AND CHAMBER OF UNOMETER PRODUCT¿ CANNOT BE IDENTIFIED ON THE BASE OF INFORMATION RECEIVED. NO CORRECTIVE ACTION IS REQUIRED. NO ADDITIONAL INVESTIGATION IS NEEDED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT REPORTED BY A NURSE THAT "THE ANTIREFLUX VALVE, DOES NOT ALLOW TO FLOW THE URINE THROUGH THE TUBE (BETWEEN THE CONNECTOR AND THE CATHETER)." THE PRODUCT WAS USED, BUT NO PATIENT HARM WAS REPORTED. IT WAS ALSO REPORTED THAT SEVERAL BOXES FROM THE SAME LOT WERE REPLACED BY THE SALES REP AT THE REQUEST OF THE CUSTOMER AS A PREVENTIVE MEASURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105114 TBD DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG 509045 210521

    Patients

    Seq Age Sex Outcome Treatment
    1