BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGUIDE CHRONIC DIALYSIS CATHETERS

    MDR report key: 2163448 · Received June 2, 2011

    Report

    Report Number
    1721504-2011-00200
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    January 4, 2011
    Report Date
    May 11, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    MSD
    PMA / PMN Number
    K042016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. THE LOT NUMBER IS UNK. THE FOLLOWING INFO WAS FOUND ON THE MAUDE DATABASE: (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFO BECOMES AVAILABLE. EVAL CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HUB ON THE INDWELLING TUNNELED HEMODIALYSIS CATHETER WAS CRACKED. NO FURTHER INFO WAS PROVIDED. NO HARM OR INJURY WAS REPORTED. MERIT BECAME AWARE OF THIS COMPLAINT WHILE GATHERING INFO FROM THE MAUDE DATABASE. A MEDWATCH REPORT WAS NOT RECEIVED BY MERIT FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGUIDE CHRONIC DIALYSIS CATHETERS CATHETER, HEMODIALYSIS, IMPLANTED MSD MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1