BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET

    MDR report key: 8165534 · Received December 14, 2018

    Report

    Report Number
    1820334-2018-03756
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 16, 2015
    Report Date
    December 14, 2018
    Manufacturer
    COOK INC
    Product Code
    GBZ
    UDI-DI
    00827002069299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO PATIENT USE UPON OPENING THE PACKAGE, THE SHEATH AND HEMOSTASIS VALVE OF THE ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET WERE FOUND SEPARATED. THIS PACKAGE WAS NOT USED, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003120 ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET GBZ CATHETER, CHOLANGIOGRAPHY GBZ COOK INC NA 5007363 00827002069299

    Patients

    Seq Age Sex Outcome Treatment
    1