BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 FR S/L PER-Q-CATH PLUS INTERMEDIATE TRAY

    MDR report key: 2182273 · Received July 12, 2011

    Report

    Report Number
    3006260740-2011-00219
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 20, 2011
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K954104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF CATHETER BREAKAGE IS CONFIRMED. THE CHARACTERISTICS OF THE DAMAGE FOUND ON THE COMPLAINT SAMPLE ARE CONSISTENT WITH A TENSILE BREAK IN WHICH THE ELASTIC STRENGTH OF THE CATHETER HAS BEEN EXCEEDED. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS, FUNCTIONAL AND TACTUAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MFG PROCESS. NO OTHER COMPLICATIONS WITH THIS DEVICE ARE KNOWN. THIS IMPLIES THE DEVICE FUNCTIONED AS DESIGNED UNTIL THE COMPLAINT INCIDENT OCCURRED. AT THIS TIME THE MECHANISM OF DAMAGE IS UNDETERMINED. THE PRODUCT INSTRUCTIONS FOR USE (IFU) PROVIDE WRITTEN DIRECTIONS FOR SECURING THE CATHETER AS WELL AS A WARNING THAT EXCESSIVE TENSION CAN CAUSE THE CATHETER TO RUPTURE. A LOT HISTORY REVIEW (LHR) IS NOT POSSIBLE, AS NO MFG LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE WHITE TUBING BROKE. REMOVED ALL PIECES FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 FR S/L PER-Q-CATH PLUS INTERMEDIATE TRAY LJS C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention