BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER¿ SAFETI¿ PLUS- WITH LUER - LOCK & LUER

    MDR report key: 6083227 · Received November 7, 2016

    Report

    Report Number
    3007966929-2016-00101
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 21, 2016
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EXP DATE: 12/2020. MFR DATE: 01/2016. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A PRODUCT MALFUNCTION. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON NOVEMBER 07, 2016.

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW INDICATE NO DISCREPANCIES RELATED TO COMPLAINT ISSUE. THE DEVICE HISTORY RECORDS WERE REVIEWED. STERILIZATION WAS PERFORMED IN ACCORDANCE WITH PARAMETERS. THE BATCH WAS RELEASED ACCORDING TO REQUIREMENTS. THE BATCH RECORD REVIEW RESULTED IN A PREVIOUS DISCREPANCY WHICH WAS INVESTIGATED VIA A PREVIOUS COMPLAINT, AND IS NOW CLOSED. THE PREVIOUS INVESTIGATION NOTED - LOSS OF PHYSICAL INTEGRITY OF UM SAFETI PLUS PRODUCT" IS VALID. ON THE BASIS OF INFORMATION RECEIVED THE INVESTIGATION CONCLUDES THAT THE TRUE ROOT CAUSE FOR THE ISSUE "LOSS OF PHYSICAL INTEGRITY OF UNOMETER SAFETI PLUS PRODUCT" CANNOT BE IDENTIFIED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THE MOMENT. NO ADDITIONAL INVESTIGATION IS NEEDED. A PHOTOGRAPH HAS BEEN RECEIVED FOR THIS COMPLAINT, WHICH WAS EVALUATED. 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. REPORTED TO THE FDA ON NOVEMBER 23, 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE NON-RETURN VALVE OF THE PRODUCT IS BROKEN." DEVICE WAS NOT USED. PHOTOGRAPH PROVIDED DEPICTING THE REPORTED COMPLAINT ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732932 UNOMETER¿ SAFETI¿ PLUS- WITH LUER - LOCK & LUER DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG UNOMEDICAL LTD. 158100140190 220378

    Patients

    Seq Age Sex Outcome Treatment
    1