BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET

    MDR report key: 8167900 · Received December 16, 2018

    Report

    Report Number
    1820334-2018-03823
    Event Type
    Malfunction
    Date Received
    December 16, 2018
    Date of Event
    November 27, 2015
    Report Date
    December 16, 2018
    Manufacturer
    COOK INC
    Product Code
    GBZ
    UDI-DI
    00827002028470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    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 THE CONCORD ENDOSCOPIC CHOLANGIOGRAPHY CATHETER WAS LEAKING AT THE CONNECTION SITE WHEN BEING FLUSHED. ANOTHER DEVICE WITH THE SAME LOT WAS OPENED AND ENCOUNTERED THE SAME LEAKAGE PROBLEM. A DIFFERENT CATHETER WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THE DEVICE WAS LEAKING AT THE HUB. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007192 CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET GBZ CATHETER, CHOLANGIOGRAPHY GBZ COOK INC NA 6211345 00827002028470

    Patients

    Seq Age Sex Outcome Treatment
    1