BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD

    MDR report key: 813523 · Received February 6, 2007

    Report

    Report Number
    MW1041886
    Event Type
    Other
    Date Received
    February 6, 2007
    Date of Event
    January 4, 2007
    Report Date
    January 29, 2007
    Manufacturer
    BARD ACCESS SYSTEMS, INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME TO INFUSION CENTER WITH LEAKING PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) LINE THAT APPEARED TO BE BROKEN. LINE WAS SENT TO MFR - BARD. NOTE: 01/20/07, BARD RESPONDED TO OUR INQUIRY: WE HAVE COMPLETED THE EVALUATION ON THE ABOVE REFERENCED PRODUCT RETURNED TO US. WE APPRECIATE YOUR ALLOWING US TO EVALUATE THE PRODUCT, AND OFFER OUR SINCERE APOLOGIES FOR ANY DIFFICULTY OR INCONVENIENCE THAT MAY HAVE OCCURRED FOR YOU OR YOUR FACILITY. BARD ACCESS SYSTEMS REC'D A REPORT FROM YOUR FACILITY THAT THE CATHETER BROKE, IT WAS NOT CUT. A D/L GROSHONG NXT PICC WAS RETURNED AND EVALUATED IN THE BAS PRODUCT TESTING LABORATORY. THE CATHETER WAS REC'D IN THREE SEGMENTS. THERE WAS A BREAK IN THE D/L TUBING AT THE DISTAL END OF THE WHITE BIFURCATION AND A CUT IN THE TUBING BETWEEN THE 39 AND 40 CM DEPTH MARK. THE CROSS SECTIONS OF THE D/L TUBING WERE MICROSCOPICALLY EXAMINED. THE BREAK AT THE BIFURCATION EXHIBITED A ROUGH AND JAGGED SURFACE. THE EXACT CAUSE OF THE BREAK IS UNKNOWN. THE CUT NEAR THE 40 CM DEPTH MARK EXHIBITED A GLOSSY AND STRIATED SURFACE, WHICH IS TYPICAL OF A CUT MADE WITH A SHARP INSTRUMENT. EXAMINATION OF THE DEVICE SHOWS NO EVIDENCE OF MATERIAL OR MANUFACTURING RELATED DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD CATHETER - 4F SINGLE LUMEN LINE LJS BARD ACCESS SYSTEMS, INC PRODUCT NO. 7927507 REQH0547

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other