BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRI PORT W/ATTACHABLE 6.6F OPEN ENDED SL

    MDR report key: 4273834 · Received November 18, 2014

    Report

    Report Number
    3006260740-2014-00571
    Event Type
    Death
    Date Received
    November 18, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    PMA / PMN Number
    K873213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) OF REXG1515 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINTS FROM THESE LOT NUMBER. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIPE WAS LEAKING AFTER 2 OR 3 APPLICATIONS OF CHEMOTHERAPEUTICS AND THE CHEMOTHERAPEUTICS WERE DISPENSED ON THE LEFT SIDE OF THE BODY AND ARM INWARDLY. ON (B)(6) 2014 SOME TIME LATER (NO DATE PROVIDED ON HANDWRITTEN PAGE) THE PORT SYSTEM WAS EXPLANTED IN TOTAL DUE TO AN ALLEGED INFECTION AFTER CHEMOTHERAPY INFUSION AND PORT LEAKAGE. AROUND THE PORT NECROTIC TISSUE WAS NOTICED (WOUND CAVITY ABOUT 3X3 CM), DEBRIDEMENT, AN OPRACLEAN-TEMPONADE AFTER FLUSHING WITH LOWAMID WAS CONDUCTED BEFORE CLOSING THE WOUND. DUE TO THE LARGE INFLAMMATION AND THE BAD CONDITION OF THE PT NO NEW PORT WAS IMPLANTED. THE CHEMOTHERAPY MUST BE CANCELLED . ON (B)(6) 2014, RECEIVED REPORT FROM THE PT'S FAMILY THAT THE CHEMOTHERAPY LEAK WEAKENED THE PT'S BODY BECAUSE THE CHEMO WAS NOT INFUSED TO THE INTENDED LOCATION AND THE RESULTING INFECTION HASTENED THE PT'S DEATH. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744002 MRI PORT W/ATTACHABLE 6.6F OPEN ENDED SL LJT BARD ACCESS SYSTEMS REXG1515

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death