BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON-PRATT CHANNEL DRAIN

    MDR report key: 8914878 · Received August 21, 2019

    Report

    Report Number
    8030107-2019-00010
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    June 7, 2019
    Report Date
    July 11, 2019
    Manufacturer
    DEGANIA SILICONE LTD
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    8030107-06/28/2019-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONNECTION STRENGTH BETWEEN THE CLEAR TUBE AND WHITE PORTION OF THE DRAIN GLUED TO THE CLEAR TUBE WAS TESTED IN THE RETAIN SAMPLE FROM THE SAME LOT AND FOUND TO BE VERY STRONG (TWICE ABOVE THE MINIMAL REQUIREMENT). IN 2019 WE OBSERVE HAVE SHARP INCREASE OF REPORTS ON BREAKAGE IN THESE DRAINS DURING USE, IN CONNECTION AREA. THE BREAKAGE WAS ASSOCIATED WITH THE NEW TOOL USED FOR THE PRODUCTION OF CONNECTOR WHICH CONNECTS CLEAR TUBE AND WHITE DRAINING PORTION IN THESE DRAINS. FOLLOWING THIS INCREASED RATE, ON 06/28/2019, DEGANIA INITIATED RECALL #8030107-06/28/2019-001-R TO REMOVE ALL DRAINS IN WHICH NEW DESIGN OF CONNECTORS WAS USED.

    Description of Event or Problem · 1

    PART OF THE DRAIN SPLIT AND REMAINED ON THE CUSTOMER'S BODY. A SECOND OPERATION WAS PERFORMED TO REMOVE THE PART OF THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711160 JACKSON-PRATT CHANNEL DRAIN SILICONE FLUTED 15FR DRAIN GCB DEGANIA SILICONE LTD JP-2189 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention