BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL ROUND DRAIN WITH TROCAR

    MDR report key: 10041571 · Received May 10, 2020

    Report

    Report Number
    8030107-2020-00007
    Event Type
    Malfunction
    Date Received
    May 10, 2020
    Report Date
    May 5, 2020
    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

    WE REVIEWED THE IN-PROCESS TEAR RESULTS OF THE INVOLVED LOT P1825299; THE MINIMUM REQUIREMENT FOR TEAR STRENGTH AT CONNECTION AREA IS 25N. THE MINIMUM TEST RESULT WAS 54.4N AND HIGHER. IT IS NOT LIKELY THAT THE DRAIN TORE FOLLOWING SOME MANUFACTURING ISSUE, AS WE SEE THAT THE CONNECTION WAS STRONG. SINCE THERE WERE NO NON-CONFORMITIES DETECTED DURING BATCH HISTORY RECORDS, AND THE IN-PROCESS TEST RESULTS WERE WELL ABOVE THE REQUIRED MINIMUM, WE CONCLUDE THAT THERE WAS NO PROBLEM WITH OUR DRAIN. THE DRAIN MOST LIKELY WAS DAMAGED IN USE AND TORE IN THE DAMAGED AREA; SILICONE DRAINS ARE KNOWN FOR THEIR ABILITY EASILY SNAP IF THEY WERE EVEN LIGHTLY CUT OR NICKED.

    Description of Event or Problem · 1

    BROKEN/CRACKED/FRACTURED DURING USE. DEFECTIVE ITEM WAS FOUND THAT SMOOTHLY CUT SURFACE AND IRREGULARITIES SURFACE. THE SCRATCH WAS FOUND NEAR THE[?]IRREGULARITIES SURFACE. THE SMOOTHLY CUT SURFACE OF THE SIMULATION TEST (THE SURFACE CUT WITH THE CUTTER) AND THE SMOOTHLY CUT SURFACE OF DEFECTIVE ITEM WERE SIMILAR. THE IRREGULARITIES SURFACE OF THE SIMULATION TEST (AFTER MAKING A SCRATCH BY STRONGLY SANDWICHING IT WITH A FORCEPS, THE SURFACE STRONGLY PULLED AND CUT) AND THE IRREGULARITIES SURFACE OF DEFECTIVE ITEM WERE ALSO SIMILAR. CUSTOMER PLACED THESE TUBES NEAR ARTIFICIAL JOINT OF KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505240 CHANNEL ROUND DRAIN WITH TROCAR SILICONE FLUTED ROUND DRAIN 10 FRENCH WITH TROCAR OTK DEGANIA SILICONE LTD 10 FRENCH P1825299

    Patients

    Seq Age Sex Outcome Treatment
    1