BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY CATHETERS

    MDR report key: 4088340 · Received August 1, 2014

    Report

    Report Number
    3005778470-2014-00053
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    FKC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ADDITIONAL INFORMATION RECEIVED ON MAY 30, 2014 INFORMING THE LEAK OF THE CATHETER VALVE REQUIRED REPLACEMENT WITH A NEW CATHETER. A QUALITY EVALUATION WAS PERFORMED ON (B)(4) 2014. THE SAMPLE IN CLOSED PEEL PACK HAS BEEN RECEIVED AND TESTED: THE VALVE WAS CONNECTED TO THE TUBE AND FILLED UP WITH COLORED WATER AND HUNG UP FOR 24 HOURS TO MONITOR THE VALVE TIGHTNESS. THE VALVES WAS OPENED AND CLOSED SEVERAL TIMES. SAMPLE MET THE TESTS REQUIREMENTS. HISTORY FILES OF THE BATCH MANUFACTURING PROCESS HAVE BEEN CHECKED. NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS. NO EARLIER COMPLAINT HAS BEEN RECEIVED ON THE BATCH IN QUESTION. BASED ON THE INVESTIGATION FINDINGS AND INFORMATION RECEIVED IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE FAILURE IN QUESTION. THERE IS NO INDICATION OF AN ADVERSE TREND OF COMPLAINTS OVER THE PAST TWELVE MONTHS FOR THIS ISSUE/PRODUCT. THE FAILURE WAS INCLUDED IN RELEVANT RISK MANAGEMENT FILE AND ASSOCIATED HAZARD WAS EVALUATED THERE. BASED ON INVESTIGATION RESULTS NO FURTHER ACTION IS REQUIRED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A LEAK WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449483 URINARY CATHETERS CLAMP, CANNULA FKC UNOMEDICAL S.R.O. 90 820 1S-10 492977

    Patients

    Seq Age Sex Outcome Treatment
    1