BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 3001638 · Received March 8, 2013

    Report

    Report Number
    1820334-2013-00120
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 14, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A FISTULOGRAM AND A CHECK FLO VALVE WAS PLACED IN A MICROPUNCTURE SHEATH. UPON REMOVING THE SHEATH, IT WAS NOTED THAT A PORTION OF THE SHEATH HAD SHEARED OFF. A LARGER INCISION WAS MADE AND THE TIP OF THE SHEATH WAS VISUALIZED AND GRASPED WITH A HEMOSTAT AND PULLED FREE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99161 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK, INC. NA 3830665

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention