BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROPUNCTURE SET

    MDR report key: 303074 · Received November 2, 2000

    Report

    Report Number
    MW4002849
    Event Type
    Other
    Date Received
    November 2, 2000
    Date of Event
    August 23, 2000
    Report Date
    September 15, 2000
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF PICC LINE IN 2000, APPROX 2CM OF THE GUIDEWIRE SHEARED OFF INTO MEDIAL ASPECT OF THE PT'S FOREARM. X-RAYS OF THE RIGHT DISTAL HUMERUS REVEALED 2CM FRAGMENT WHICH APPEARED TO BE KNOTTED AND EMBEDDED WITHIN THE SOFT TISSUE. THE GUIDEWIRE WAS LEFT EMBEDDED WITHIN SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE SET PICC LINE DYB COOK, INC. MPIS 501 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other