BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 FR S/L PER-Q-CATH SILICONE PERCUTANEOUS CVC W/EXCALIBUR INT

    MDR report key: 1944208 · Received December 6, 2010

    Report

    Report Number
    3006260740-2010-00363
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    September 8, 2010
    Report Date
    November 12, 2010
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K954104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CONNECTED THE SYRINGE TO THE CATHETER, THE CATHETER BROKE COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 FR S/L PER-Q-CATH SILICONE PERCUTANEOUS CVC W/EXCALIBUR INT LJS C. R. BARD, INC. (BASD) RETC0019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention