BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETER

    MDR report key: 691643 · Received March 22, 2006

    Report

    Report Number
    1036844-2006-00019
    Event Type
    Injury
    Date Received
    March 22, 2006
    Date of Event
    February 22, 2006
    Report Date
    March 21, 2006
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL ON 2/22/2006, CATHETER BROKE OFF IN PT'S BACK. SURGERY WAS COMPLETED LATER TO REMOVE CATHETER TIP. THERE WERE NO ASSOCIATED PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETER ANESTHESIA PRODUCTS BSO ARROW INTERNATIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention