BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETRAC DUAL WIRE INSERTION KIT

    MDR report key: 530911 · Received March 2, 2004

    Report

    Report Number
    1223643-2004-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2004
    Date of Event
    January 12, 2004
    Report Date
    February 25, 2004
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Product Code
    MSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CATHETER STIFFENER BROKE INSIDE THE CATHETER DURING PLACEMENT OF A 32 CM XPRESSO CATHETER. THE DILATOR BROKE IN TWO AND THE PIECE OF THE DILATOR INSIDE THE CATHETER HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETRAC DUAL WIRE INSERTION KIT CATHETERIZATION KIT ACCESSORY MSD SPIRE BIOMEDICAL, INC. XDWIK 32 99382577

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention