BEUDAMED
    FDA Adverse Event Death Summary report: N

    TITANIUM POWERPORT 8 FR CHRONOFLEX ATTACHA

    MDR report key: 2850851 · Received November 16, 2012

    Report

    Report Number
    3006260740-2012-00414
    Event Type
    Death
    Date Received
    November 16, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 26, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJT
    PMA / PMN Number
    K060812
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE HAS BEEN SEQUESTERED BY THE REPORTING FACILITY. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PHYSICIAN REPLACING POWERPORT WITH A NEW ONE. DIFFICULT INSERTION, DIFFICULT TO PASS WIRE THROUGH CATHETER. PULLED WIRE OUT AND IT WAS FRAYED. USED A NEW WIRE TO PLACE CATHETER. PT'S VEIN WAS BREACHED. PT DIED. HOSPITAL IS UNSURE IF THE WIRE IS WHAT CAUSED THE PT'S DEATH. ADDITIONAL INFORMATION: AUTOPSY PERFORMED, FOUND VESSEL PERFORATION CAUSED PT TO EXSANGUINATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM POWERPORT 8 FR CHRONOFLEX ATTACHA LJT C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death