BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET

    MDR report key: 8167642 · Received December 15, 2018

    Report

    Report Number
    1820334-2018-03757
    Event Type
    Malfunction
    Date Received
    December 15, 2018
    Report Date
    December 15, 2018
    Manufacturer
    COOK INC
    Product Code
    GBZ
    UDI-DI
    00827002069299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 DURING A PROCEDURE WITH THE ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET, THE PHYSICIAN FOUND THAT THE DIRECTIONAL MARK WAS NO LONGER FIXED AND WAS TURNING WITH THE NEEDLE, WHICH MADE THE PROCEDURE ¿NOT SECURE¿ AND REQUIRED ADDITIONAL TIME AND X-RAY EXPOSURE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006747 ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET GBZ CATHETER, CHOLANGIOGRAPHY GBZ COOK INC NA 5208648 00827002069299

    Patients

    Seq Age Sex Outcome Treatment
    1