BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH

    MDR report key: 513766 · Received March 3, 2004

    Report

    Report Number
    513766
    Event Type
    Other
    Date Received
    March 3, 2004
    Date of Event
    December 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    BD INFUSION THERAPY SYSTEMS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV THERAPIST INSERTING 18 GAUGE L-CATH PICC LINE EXPERIENCED GREAT DIFFICULTY REMOVING THE GUIDEWIRE. REMOVAL OF THE GUIDEWIRE REQUIRED EXTENSIVE MANIPULATION AND THE ASSISTANCE OF A 2ND IV THERAPIST. DUE TO CONCERN REGARING THE DEGREE OF MANIPULATION REQUIRED TO REMOVE THE GUIDEWIRE, THE PT HAD 2 CHEST X-RAYS TO VERIFY THE CATHETER PLACEMENT BUT ALSO TO ASSESS THE INTEGRITY OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD L-CATH L-CATHETER, PICC LINE DQO BD INFUSION THERAPY SYSTEMS, INC. * 3073426

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other