BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON-PRATT CHANNEL DRAIN

    MDR report key: 9375035 · Received November 26, 2019

    Report

    Report Number
    8030107-2019-00022
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    July 19, 2019
    Report Date
    November 26, 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 LOT NUMBER OF THE BROKEN DEVICE IS UNKNOWN; THE DEVICE PROBABLY BELONGS TO ONE OF THE LOTS AFFECTED BY RECALL. 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

    AFTER WHIPPLE PROCEDURE, THE PATIENT CAME FOR AN OFFICE VISIT FOR RIGHT UPPER QUADRANT PAIN AND DECREASED DRAINAGE FROM THE JP TUBE. AN ABDOMINAL CT NOTED A SEPARATION OF THE CLEAR PORTION OF THE JP DRAIN FROM THE WHITE PORTION. PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY FOR REMOVAL OF RETAINED PORTION OF THE DRAIN, AND REPLACEMENT OF SECOND DRAIN. THE WHITE PORTION OF THE DRAIN WAS TUNNELING OUT BETWEEN LOOPS OF BOWEL AND THERE WAS CLOUDY PANCREATIC TYPE FLUID COMING OUT FROM THIS TRACT ONCE THE FLUTED DRAIN WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170314 JACKSON-PRATT CHANNEL DRAIN SILICONE FLUTED 15FR DRAIN GCB DEGANIA SILICONE LTD JP-2189 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention