BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORT M.R.I. PORT W/ATTACHABLE 6.6F OPEN ENDED SL

    MDR report key: 4414321 · Received January 12, 2015

    Report

    Report Number
    3006260740-2015-00012
    Event Type
    Death
    Date Received
    January 12, 2015
    Report Date
    December 24, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJT
    PMA / PMN Number
    K873213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REVB0143 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINTS FROM THESE LOT NUMBERS.

    Description of Event or Problem · 1

    ON (B)(6) 2014 PER CIR, IT WAS REPORTED THAT AFTER INTRODUCING THE NEEDLE AND THEN GUIDE WIRE, THERE WAS REPORTEDLY SIGNIFICANT HEMORRHAGE AND ALLEGEDLY THE LUNGS OF THE PT COLLAPSED. THE PT THEN EXPIRED. ON 12/30/2014 AS PER ADDITIONAL INFO RECEIVED, THE PHYSICIAN REPORTEDLY INTENDED TO IMPLANT A LOW PROFILE PORT CATALOG NUMBER 0603880 6.6 FRENCH, AND WAS GIVEN A 6.6 FRENCH PORT CATALOG NUMBER 0602690 BY THE PHARMACY. THE DR ALLEGES THAT THE PRODUCT HE RECEIVED IS INTENDED FOR ADULT USE AND NOT FOR PEDIATRIC PTS. DURING THE INSERTION PROCEDURE, THERE WAS SIGNIFICANT BLEEDING AND THE LUNGS REPORTEDLY COLLAPSED. THE PT RECEIVED 1 UNIT OF BLOOD TO ATTEMPT TO STABILIZE HIM AS WELL AS AN ICD BLOOD DRAINAGE DEVICE. THE PT EXPIRED LATER IN AN OUTPATIENT ROOM. THE CAUSE OF DEATH WAS STATED AS HEMORRHAGIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27787 PORT M.R.I. PORT W/ATTACHABLE 6.6F OPEN ENDED SL LJT BARD ACCESS SYSTEMS INC. REVB0143

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Death