BEUDAMED
    FDA Adverse Event Death Summary report: N

    5 FR. D/L GROSHONG NXR W/MI AND TLS

    MDR report key: 1273592 · Received December 24, 2008

    Report

    Report Number
    3006260740-2008-00273
    Event Type
    Death
    Date Received
    December 24, 2008
    Date of Event
    November 19, 2008
    Report Date
    December 5, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063240
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED AND THE CAUSE APPEARS TO BE USER RELATED. A U-SHAPED BREAK WAS FOUND IN THE DISTAL LUMEN BETWEEN THE 43 AND 44 CM DEPTH MARKS, WHICH IS A TYPICAL CHARACTERISTIC OF A BURST. IT APPEARS THAT THE 5 FR D/L GROSHONG PICC WAS OVERPRESSURIZED. THE D/L TUBING HAD BEEN CUT NEAR THE 10CM DEPTH MARK AND THE DISTAL SEGMENT OF THE CATHETER WAS NOT RETURNED FOR EVALUATION. THE CATHETER WAS APPARENTLY KINKED AT THE BURST SITE. A SEMI-CIRCUMFERENTIAL CREASE WAS FOUND ACROSS THE U-SHAPED BREAK IN THE D/L TUBING. NO DEFECTS RELATED TO THE MANUFACTURING PROCESS WERE FOUND ON THE COMPLAINT SAMPLE. THE PRODUCT IFU STATES, "CATHETERS THAT PRESENT RESISTANCE TO FLUSHING AND ASPIRATION MAY BE PARTIALLY OR COMPLETELY OCCLUDED. DO NOT FLUSH AGAINST RESISTANCE." A CHR WAS NOT COMPLETED SINCE THE LOT INFORMATION WAS NOT PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    AN EXTERNAL HOLE WAS DISCOVERED IN THE PICC LINE. THE DEVICE WAS PLACED 2008. THREE DAYS PRIOR TO THE LAST DRESSING CHANGE, THE PATIENT HAD A NORMAL CT SCAN. THE DRESSING WAS CHANGED EARLY IN THE MORNING AND THE FOLLOWING DAY THE PATIENT WAS DISCOVERED LYING IN A POOL OF BLOOD. ANOTHER CT SCAN WAS PERFORMED AND MULTIPLE BRAIN AIR EMBOLISMS WERE DISCOVERED. THAT PATIENT DIED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR. D/L GROSHONG NXR W/MI AND TLS LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death