BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAIN FLAT 07MM (PERFORATED 4/4)

    MDR report key: 10275796 · Received July 15, 2020

    Report

    Report Number
    8030107-2020-00018
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    July 15, 2020
    Manufacturer
    DEGANIA SILICONE LTD
    Product Code
    OTK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THERE WERE NO NON-CONFORMITIES DETECTED DURING BATCH HISTORY RECORDS, AND THE IN-PROCESS TEST RESULTS AND UNUSED SAMPLES TEST RESULTS WERE WELL ABOVE THE REQUIRED MINIMUM OF 45N, WE CONCLUDE THAT THERE WAS NO PROBLEM WITH OUR PARTS. THE DRAINS MOST LIKELY WERE 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. THE COMPLAINT CONSIDERED TO BE NOT JUSTIFIED.

    Description of Event or Problem · 1

    WHEN PULLING THE RETROSTERNAL DRAINAGE, TEAR OFF THE DRAIN 3MM BEFORE WRAPPING AND KNOTTING THE DRAINAGE BY THE PEDIATRIC CARDIAC SURGEON. DRAIN KNOT / THREAD WAS FIRST LOOSENED EASILY BETWEEN THE SKIN AND DRAIN. ALREADY WHEN GRASPING THE DRAIN WITH A SLIGHT PULL, THE DRAIN WAS TORN OFF. THE REMAINING RETROSTEMAL DRAINAGE REMAINED IN THE CHEST, WHICH MADE PEDIATRIC SURGERY NECESSARY. SECOND INCIDENT OF THIS TYPE WITH NEW DRAINAGE, SAME TEAR-OFF POINT AS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744542 DRAIN FLAT 07MM (PERFORATED 4/4) SILICONE FLAT DRAIN 7 MM OTK DEGANIA SILICONE LTD 7 MM P1867072

    Patients

    Seq Age Sex Outcome Treatment
    1