BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSO-PRATT FLUTED ROUND SILICONE DRAIN 15 FR

    MDR report key: 10041572 · Received May 10, 2020

    Report

    Report Number
    8030107-2020-00001
    Event Type
    Malfunction
    Date Received
    May 10, 2020
    Date of Event
    April 17, 2019
    Report Date
    May 10, 2020
    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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BREAKAGE WAS ASSOCIATED WITH THE NEW TOOL USED FOR THE PRODUCTION OF CONNECTOR PN 3140051501 WHICH CONNECTS CLEAR TUBE AND WHITE DRAINING PORTION IN THESE DRAINS (SEE BELOW THE VISUAL DIFFERENCE BETWEEN TWO DESIGNS OF CONNECTORS). THE CHANGE OF DESIGN WAS INITIALLY REQUESTED FOR DIFFERENT PART NUMBER OF CONNECTOR, PRODUCED BY THE SAME TOOL. BY MISTAKE, THE CHANGE WAS APPLIED TO ALL THE CONNECTORS PRODUCED BY THIS TOOL. ON (B)(6) 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

    THE WOUND DRAIN BROKE OFF INSIDE THE PATIENT. NO PATIENTS WERE INJURED. AS THE DRAIN WAS BEING REMOVED FROM THE PATIENT, THE DRAIN BROKE AND PART OF IT REMAINED INSIDE THE PATIENT'S ABDOMEN. THE ADVERSE EFFECT WAS THAT THE PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE THE RETAINED PORTION OF THE DRAIN. THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505241 JACKSO-PRATT FLUTED ROUND SILICONE DRAIN 15 FR JP CHANNEL DRAIN 15FR, FULL FLUTES GCB DEGANIA SILICONE LTD JP-2188 P1849762

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention