BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXUFLOW FLAT FULL DUCT 10MM

    MDR report key: 12663770 · Received October 20, 2021

    Report

    Report Number
    8030107-2021-00011
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Report Date
    October 19, 2021
    Manufacturer
    DEGANIA SILICONE LTD
    Product Code
    OTK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH NUMBER IS UNKNOWN, SO WERE UNABLE TO EVALUATE THE SPECIFIC PRODUCTION REPORTS. OUR IN-PROCESS CONTROL CONTAINS TENSILE STRENGTH TEST OF EVERY BATCH OF THE DRAINS AND 100% VISUAL INSPECTION. WE CHECKED THE TENSILE STRENGTH REPORTS OF THE RECENT BATCH OF ORHUF100 (P2139871) AND THEY SHOW IN-SPEC RESULTS. THE COMPLAINT SAMPLE WAS UNAVAILABLE FOR OUR EVALUATION AND THE BATCH NUMBER IS UNKNOWN. OUR IN-PROCESS CONTROL CONTAINS TENSILE STRENGTH TEST OF EVERY BATCH (INCLUDING CONNECTION AREA WHERE THE DRAIN TORE) AND 100% VISUAL INSPECTION. NO SHARP OBJECTS ARE PRESENT ON THE WORKSTATIONS. BASED ON THE ABOVE DATA, WE CONCLUDE THAT POSSIBILITY THAT THE DRAIN TORE FOLLOWING ANY MANUFACTURING REASON IS REMOTE; DRAIN MOST PROBABLY FAILED DUE TO SOME DAMAGE IN USE. ONE OF THE PROPERTIES OF SILICONE DRAINS IS TO SNAP EASILY IN PLACE OF SLIGHT CUT OR NICK. THE COMPLAINT CONSIDERED TO BE NOT JUSTIFIED. NO CAPA IS REQUIRED IN THIS CASE.

    Description of Event or Problem · 1

    BROKEN AT THE JOINT OF THE DRAIN TUBE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565260 EXUFLOW FLAT FULL DUCT 10MM EXUFLOW FLAT FULL DUCT 10MM OTK DEGANIA SILICONE LTD 10MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1