BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERIFIX

    MDR report key: 376291 · Received February 7, 2002

    Report

    Report Number
    2523676-2002-00002
    Event Type
    Other
    Date Received
    February 7, 2002
    Date of Event
    November 14, 2001
    Report Date
    February 1, 2002
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE FOLLOWING: CATHETER TIP SHEARED OFF IN PT WHILE REMOVING. AT PRESENT, CATHETER FRAGMENT REMAINS ASYMPTOMATICALLY IN PT'S BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIFIX EPIDURAL CATHETER CAZ B. BRAUN MEDICAL, INC. CE17TO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other