BEUDAMED
    FDA Adverse Event Death Summary report: N

    5 FR DL POWERPICC SOLO CATHETER, FULL TRAY WITH TLS

    MDR report key: 1658012 · Received April 9, 2010

    Report

    Report Number
    3006260740-2010-00081
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    January 4, 2010
    Report Date
    March 16, 2010
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION. TWO POTENTIAL LOT NUMBERS HAVE BEEN IDENTIFIED FOR THIS COMPLAINANT FROM FACILITY SALES. BECAUSE IT IS UNCLEAR WHICH LOT NUMBER WAS USED FOR THIS CASE, THE CORPORATE LOT NUMBER FIELD WILL BE INDICATED UNK. A CHR WILL BE COMPLETED ON BOTH LOT NUMBERS IDENTIFIED. (B) (4). THE CHR REVIEW FOR LOT# RETK0143 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S).

    Description of Event or Problem · 1

    WHEN THE RN FLUSHED THE LINE WITH SALINE, PT'S "EYES ROLLED BACK" AND THE PT WENT UNRESPONSIVE. PT WAS HYPOTENSIVE AND BRADYCARDIC AND A LEFT-SIDED FACIAL DROOP WAS NOTED. THE PT WAS DNR STATUS AND AFTER NOT RESPONDING TO A FLUID BOLUS AND OXYGEN BAGGING, WAS ALLOWED TO EXPIRE. THE RECORDED CAUSE OF DEATH WAS ACUTE MYOCARDIAL INFARCTION, BUT NO AUTOPSY WAS PERFORMED AS THE PT WAS DNR. PORTABLE CHEST X-RAY WAS DONE AND FOUND TO BE "UNDER-ADVANCED". INSERTION WAS DONE UNDER ULTRASOUND GUIDANCE. THERE WERE NO SIGNS OF PERFORATION OR BLEEDING. PROPER PROCEDURES, USING LIDOCAINE AND NORMAL SALINE, WERE REPORTEDLY FOLLOWED; AND IT WAS STATED, "THERE WERE NO SIGNS OF AIR EMBOLISM." CHEST X-RAY DID NOT SHOW SIGNS OF MIGRATION OR EMBOLISM OF DEVICE COMPONENTS. LINE REPORTEDLY HAD "GOOD BLOOD RETURN, AND FLUSHED WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL POWERPICC SOLO CATHETER, FULL TRAY WITH TLS LJS C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death