BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC 4.2 FR CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF

    MDR report key: 1852085 · Received September 28, 2010

    Report

    Report Number
    3006260740-2010-00277
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 9, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF LEAK IS CONFIRMED. DURING INFUSION, A LEAK WAS OBSERVED IN THE CATHETER. THE LOCATION OF THE PINHOLE LEAK IS 1.1 INCHES DISTAL TO THE SURECUFF. MICROSCOPIC EXAM SHOWS A SMALL TEAR IN THE TUBING. THE COMPLAINANT INDICATES THE LEAK WAS OBSERVED 17 DAYS AFTER PLACEMENT. AT THIS TIME, THE EXACT MECHANISM OF THE DAMAGE IS UNK. A CHR IS NOT POSSIBLE, AS NO MFG LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    DAMAGED CATHETER WAS FOUND. THE INDWELLING PERIOD WAS 17 DAYS. THE DEVICE WAS PLACED ON (B)(6) VIA THE RIGHT SUBCLAVIAN VEIN FOR TPN INFUSION AND BLOOD DRAWING. ON (B)(6), THE PT LEFT THE HOSP FOR A NIGHT AND THE DEVICE WAS MAINTAINED USING HEPARIN LOCK. ON (B)(6), PRE ASPIRATE CHECK WAS PERFORMED BEFORE TPN INFUSION AND FAILED. HOWEVER, THE DEVICE WAS USED FOR THE INFUSION BUT THE INFUSION WAS DISCONTINUED BECAUSE THE PT ALSO REPORTED TO FEEL PAIN AND COLDNESS DURING THE INFUSION. THE DEVICE WAS REMOVED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROVIAC 4.2 FR CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention