BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH

    MDR report key: 513759 · Received March 3, 2004

    Report

    Report Number
    513759
    Event Type
    Other
    Date Received
    March 3, 2004
    Date of Event
    December 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    BD INFUSION THERAPY SYSTEM 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 [PERIPHERIAL INSERTED CENTRAL CATHETER] LINE EXPERIENCED GREAT DIFFICULTY REMOVING THE GUIDEWIRE. REMOVAL OF THE GUIDEWIRE REQUIRED EXTENSIVE MANIPULATION, RESULTING IN A SMALL HOLE AT THE HUB OF THE CATHETER. THE HOLE WAS SUCCESSFULLY REPAIRED. DUE TO CONCERN REGARDING THE DEGREE OF MANIPULATION REQUIRED, THE PT HAD 2 CHEST X-RAYS TO VERIFY CATHETER PLACEMENT BUT ALSO TO ASSESS THE INTEGRITY OF THE CATHETER. THERE IS ANOTHER GUIDEWIRE ISSUE WITH THIS BRAND OF CATHETER THIS SAME DAY WITH ANOTHER PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD L-CATH L-CATHETER, PICC LINE DQO BD INFUSION THERAPY SYSTEM INC 384408 3073426

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other