BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH

    MDR report key: 469626 · Received July 1, 2003

    Report

    Report Number
    1710034-2003-00039
    Event Type
    Other
    Date Received
    July 1, 2003
    Date of Event
    May 23, 2003
    Report Date
    May 28, 2003
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CATHETER BROKE ABOUT 1 CM BELOW THE CATHETER HUB WHILE IN THE PATIENT. FAMILY MEMBER NOTICED AND INFORMED NURSING. THE CATHETER WAS REMOVED WITHOUT INCIDENT. NO MEDICAL OR SURGICAL INTERVENTION REQUIRED TO REMOVE THE CATHETER. 2 FR CATHETER BROKEN AT HUB. REPORTED BY PATIENT'S FAMILY MEMBER. DENIES PULLING ON CATHETER. HEPARIN DRIP INFUSING. LINE WAS IN 3 DAYS PRIOR TO INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD L-CATH PERCUTANEOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA 112316

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention