BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREVI-XL/2

    MDR report key: 362860 · Received November 27, 2001

    Report

    Report Number
    1316297-2001-00002
    Event Type
    Other
    Date Received
    November 27, 2001
    Date of Event
    October 31, 2001
    Report Date
    November 26, 2001
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR. WAS PERFORMING LYSIS PROCEDURE. AS PROCEDURE WAS BEING PERFORMED, A TOTAL OF FOUR (4) CATHETERS WERE SHEARED WITH AN EPIDURAL NEEDLE. THE TIP OF ONE OF THE CATHETERS REMAINED IN THE PATIENT. (2MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53336 BREVI-XL/2 EPIDURAL CATHETER BSO EPIMED INTERNATIONAL, INC. NA 1108536

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR RK NEEDLE, 16 GA.