BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL

    MDR report key: 542076 · Received August 12, 2004

    Report

    Report Number
    542076
    Event Type
    Malfunction
    Date Received
    August 12, 2004
    Date of Event
    August 1, 2004
    Report Date
    August 12, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE MATERIAL USED IN THE CATHETER IS PRONE TO CRACKING AND LEAKING. THE CRACKS TEND TO OCCUR IN THE CATHETER JUST PAST THE SUTURE BLOCK, INTERNAL TO THE PATIENT. COMPANY HAS EXPERIENCED APPROXIMATELY A 5% FAILURE RATE WITH THE 3F,4F AND 4.5F CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PICC CATHETER 3F LJS BOSTON SCIENTIFIC CORPORATION 3F 3F 913661, 3F 917962,
    2 VAXCEL PICC CATHETER 4F LJS BOSTON SCIENTIFIC COROPORATION 4F 4F 4020603339, 4F 908786
    3 VAXCEL PICC CATHETER 4.5F LJS BOSTON SCIENTIFIC CORPORATION 4.5F 4.5F 942771, 4.5F 908789,

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES