BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHEMO-CATH WITH INTRODUCER

    MDR report key: 515289 · Received March 6, 2004

    Report

    Report Number
    2925153-2003-00020
    Event Type
    Other
    Date Received
    March 6, 2004
    Date of Event
    September 5, 2003
    Report Date
    March 6, 2004
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCTS HAVE BEEN IN USE FOR THE PAST 2-3 YEARS. OF LATE NUMEROUS DEFECTS ARE BEING NOTICED RESULTING IN UNNECESSARY INTERVENTIONS IN ALREADY COMPROMISED CANCER PATIENTS. THEIR DEFECTS ARE BREAKAGE, KINKING OF THE CATHETER, KINKING OF THE GUIDEWIRES, BREAKAGE OF THE CATHETER AT SITE OF SKIN ENTRY, LEAKING OF CATHETER WITHIN THE TUNNEL LEADING TO EXTRAVASATION AND INFECTION, BREAKING OF OCCLUSION CLAMPS, BREAKING OF THE LUER TIPS OF THE CATHETER. ALL OF THESE HAVE RESULTED IN CONSIDERABLE PATIENT SUFFERING AND DELAYS AND STOPPAGES IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMO-CATH WITH INTRODUCER CHEMO-CATH DQO HDC CORP. 335-10 1002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other