BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

    MDR report key: 7525836 · Received May 18, 2018

    Report

    Report Number
    1820334-2018-01484
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 26, 2016
    Report Date
    May 18, 2018
    Manufacturer
    COOK INC
    Product Code
    MPB
    UDI-DI
    00827002350823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: MPB CATHETER, HEMODIALYSIS, NON-IMPLANTED. PRODUCT CODE: MPB. 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

    THE COMPLAINANT REPORTED THAT THE WIRE UNTANGLED DURING INSERTION OF THE COOK TURBO-FLO HD HEMODIALYSIS CATHETER INTO THE RIGHT INTRA JUGULAR VEIN. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369352 COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET MPB COOK INC G35082 00827002350823

    Patients

    Seq Age Sex Outcome Treatment
    1