BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JELCO

    MDR report key: 2240784 · Received September 6, 2011

    Report

    Report Number
    MW5022132
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 29, 2011
    Manufacturer
    SMITH MEDICAL ASD., INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV CATHETER SHEARED OFF ON REMOVAL. IV LEFT HAND NOTED TO BE LEAKING AT INSERTION SITE. CONNECTION CHECKED AND RETAPED. CONTINUED TO LEAK FROM INSERTION SITE. IV REMOVED. CATHETER SHEARED OFF AND REMAINED IN PT. PT REQUIRED CUT-SOWN AT SITE TO REMOVE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO PROTECTIV SAFETY I.V. CATHETER FOZ SMITH MEDICAL ASD., INC. 3057 ST 2012174

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention