BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

    MDR report key: 6184865 · Received December 19, 2016

    Report

    Report Number
    1820334-2016-01511
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 23, 2016
    Report Date
    June 29, 2017
    Manufacturer
    COOK INC
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. COMMON DEVICE NAME MPB. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    510K: K161504. A REVIEW OF THE DRAWINGS, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FACILITY IS EXPERIENCING CATHETER FAILURES DUE TO ACCESS PRESSURE ISSUES FOR THIS PRODUCT LINE. THE REPORTER ONLY INDICATED, ¿PRODUCT WAS USED IN PROCEDURE.¿ AS OF THE DATE OF THIS REPORT THE QUANTITY, LOT NUMBERS AND ANY PATIENT INVOLVEMENT HAVE NOT BEEN CLARIFIED BY THE REPORTER. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836123 COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY MPB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1