BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN 12 FR DUAL-LUMEN CV CATHETER, CUTDOWN

    MDR report key: 2142055 · Received May 19, 2011

    Report

    Report Number
    3006260740-2011-00143
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 27, 2011
    Manufacturer
    C. R. BARD, INC., (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF CATHETER LEAK (PARTIAL BREAK) IS CONFIRMED. A PARTIAL BREAK IN THE TUBING HAS BEEN IDENTIFIED 3.1 INCHES PROXIMAL TO THE DISTAL TIP OF THE CATHETER AT THE DISTAL END OF THE BIFURCATION SITE. GROSS AND MICROSCOPIC EXAMINATIONS OF THE BREAK SITE SHOW BROKEN EDGES AND GRANULAR CROSS SECTIONAL VENEER THAT IS CONSISTENT WITH A BREAK IN THE TUBING AS OPPOSED TO A CUT WITH A SHARP INSTRUMENT. DURING FUNCTIONAL TESTING WATER WAS OBSERVED EXITING THE PARTIAL BREAK SITE. AT THIS TIME, THE EXACT MECHANISM OF DAMAGE IS UNK. NO EVIDENCE OF A MFG DEFECT OR DEFORMITY IS IDENTIFIED. AN LHR OF 43KPP009 SHOWED NO OTHER SIMILAR PRODUCT COMPLIANT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HICKMAN CATHETER WAS EXPLANTED ON (B)(6), 2011 DUE TO A LEAKAGE IN CUTANEOUS TISSUE. THE CATHETER WAS IMPLANTED ON (B)(6), 2010 IN THE RIGHT V. JUGULARIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN 12 FR DUAL-LUMEN CV CATHETER, CUTDOWN LJS C. R. BARD, INC., (BASD) 43KPP009

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention