BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK DIALYSIS CATHETER

    MDR report key: 3071283 · Received April 11, 2013

    Report

    Report Number
    3071283
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HERE FOR REMOVAL OF TUNNELED VASCULAR ACCESS DEVICE DUE TO A FUNCTIONING FISTULA. UPON REMOVAL, CUFF CAME LOOSE. INCISION MADE TO FREE CUFF. NO FURTHER INTERVENTION NEEDED. HEMOSPLIT TUNNELED LOT # REVH VAD 1273, BARD HEMOSPLIT 16FR X 19CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155724 COOK DIALYSIS CATHETER BARD HEMOSPLIT 16FR X 19CM MSD BARD MEDICAL DIVISION REVH VAD 1273

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention