BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45 CM, 5FR. S/L POWERGROSHONG, BASIC KIT

    MDR report key: 2844477 · Received November 5, 2012

    Report

    Report Number
    3006260740-2012-00392
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 11, 2012
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A SUBCUTANEOUS LEAK IN THE CATHETER IS CONFIRMED. GROSS AND MICROSCOPIC EXAMINATIONS OF THE COMPLAINT SAMPLE REVEALED TWO PARTIAL TEARS IN THE CATHETER TUBING. THE TWO PARTIAL TEAR IN THE TUBING ARE LOCATED BETWEEN THE 41 AND 42 CM DEPTH MARKERS, THE SECOND PARTIAL TEAR IS OBSERVED AT THE 35 CM DEPTH MARKER. THE TWO TEARS ARE NEARLY PERPENDICULAR TO THE AXIS OF THE TUBING. BOTH TEAR SITES REVEAL ROUNDED EDGES. THE TUBING SURROUNDING THE TWO TEAR SITES ARE SLIGHTLY COMPRESSED. THESE CHARACTERISTICS OF ROUNDED EDGES AND CROSS SECTIONAL ROUGH WALLS IN THE CATHETER TUBING ARE TYPICAL OF MATERIAL FATIGUE AND FRICTION WEAR; HOWEVER, AT THIS TIME THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL, MICROSCOPIC AND FUNCTIONAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A LOT HISTORY REVIEW (LHR) OF REVK1027 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC HAD A HOLE BETWEEN THE 38-39CM MARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45 CM, 5FR. S/L POWERGROSHONG, BASIC KIT LJS C.R. BARD, INC. (BASD) REVK1027

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention