BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JP CHANNEL DRAIN 10FR HUBLESS

    MDR report key: 19015720 · Received April 1, 2024

    Report

    Report Number
    1423537-2024-00013
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 1, 2024
    Manufacturer
    DEGANIA SILICONE, INC.
    Product Code
    KGZ
    UDI-DI
    10885380182587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD REVIEW FOR BATCH NUMBER P22113862 SHOWED (B)(4) PIECES PRODUCED (B)(6) 2023 , WITH EXPIRATION DATE OF 01/24/2028. SUPPLIER¿S IN-PROCESS CONTROL CONTAINS TENSILE STRENGTH TEST OF EVERY BATCH OF THE DRAINS. THE BATCH PASSED THE TENSILE STRENGTH TEST (TEAR TEST) IN THE TUBE PART AND THE FLUTED PART ACCORDING TO THE TEST SPECIFICATION. TESTING FROM RETAINED SAMPLE FROM THE SAME BATCH PASSED TENSILE STRENGTH TEST AND THE RESULT WAS COMPLIANT WITHIN TEST SPECIFICATION. BASED ON TESTING AND THE INFORMATION PROVIDED, THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER STATED THAT THE SURGEON REPORTED THAT THE JP DRAIN BROKE OFF INSIDE OF THE PATIENT. NO INJURY WAS REPORTED. THE SURGEON IS NOT NECESSARILY ADVOCATING SOMETHING IS WRONG WITH THE PRODUCT, BUT HE DOES WANT TO BE CERTAIN THAT HIS TEAM IS USING IT IN THE MANNER IT IS DESIGNED TO BE USED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665587 JP CHANNEL DRAIN 10FR HUBLESS ACCESSORIES, CATHETER KGZ DEGANIA SILICONE, INC. JP-2226 P22113862 10885380182587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other