BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER SAFETI+HK 150CMTBNG LRL 1X10INT

    MDR report key: 8637978 · Received May 23, 2019

    Report

    Report Number
    3007966929-2019-00015
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 3, 2019
    Manufacturer
    UNOMEDICAL ZAVODSKAYA STREET 50
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: DR. (B)(6). A BATCH RECORD REVIEW WAS PERFORMED. NO NCR RELATED TO COMPLAINT ISSUE WERE INITIATED FOR COMPLAINT ORDER DURING PRODUCTION. NON-CONFORMANCE 1224741 ¿STOP FLOW FROM PATIENT TO CHAMBER¿ WAS INITIATED. ON A BASE OF THE AVAILABLE INFORMATION AND INVESTIGATION CONDUCTED THE ROOT CAUSE FOR THE ISSUE ¿STOP FLOW AT DIFFERENT AREAS FROM PATIENT TO CHAMBER WAS OBSERVED BY HCP DURING PRODUCT USE¿ CANNOT BE DETERMINED. THE LIST OF POSSIBLE CAUSES WAS DETERMINED. NO SYSTEMATIC FAILURES IN MANUFACTURING PROCESS WERE REVEALED. NO ACTIONS ARE REQUIRED AT THE MOMENT. NO SAMPLES AND PICTURES WERE RECEIVED. NO ADDITIONAL INVESTIGATION IS NEEDED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 3007966929.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE URINE IS RETAINED IN THE PROXIMAL AREA PROXIMAL TO THE CATHETER AND CAN NOT MAKE ITS WAY TO THE DRAINAGE BAG. THE RETENTION POINT IS THE WHITE FILTER". ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE CATHETER CONNECTOR IS WHERE THE "WHITE FILTER" IS LOCATED WITHIN THE PRODUCT THAT CAUSED "HINDER URINE". IT IS UNCLEAR AS TO HOW LONG THE PRODUCT WAS IN USE PRIOR TO NOTING THE STATED ISSUE. BLADDER BALLOONING WAS PERFORMED AFTER THE PRODUCT WAS REMOVED. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432043 UNOMETER SAFETI+HK 150CMTBNG LRL 1X10INT DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG UNOMEDICAL ZAVODSKAYA STREET 50 413455 202038

    Patients

    Seq Age Sex Outcome Treatment
    1