BEUDAMED
    FDA Adverse Event Other Summary report: N

    N/A

    MDR report key: 373574 · Received January 18, 2002

    Report

    Report Number
    2523676-2001-00064
    Event Type
    Other
    Date Received
    January 18, 2002
    Date of Event
    December 10, 2001
    Report Date
    January 17, 2002
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    LJS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED THE FOLLOWING: "TWO GUIDEWIRES WERE FRAYED WHEN REMOVED FROM INTRODUCERS (TWO INCIDENTS). IN ONE INCIDENT, A PIECE OF GUIDEWIRE BROKE OFF AND HAD TO BE RETRIEVED" NEITHER PATIENT SUFFERED ANY ADVERSE EFFECTS AS A RESULT OF THESE OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A MULTI-LUMEN CATHETER KIT LJS B. BRAUN MEDICAL, INC. M3712K 0060221736

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention