BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE POWERPORT MRI AIRGUARD CHRONOFLEX

    MDR report key: 7901765 · Received September 21, 2018

    Report

    Report Number
    MW5080052
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    June 12, 2018
    Report Date
    August 8, 2018
    Manufacturer
    BARD ACCESS SYSTEM, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANTABLE POWER PORT MRI AIRGUARD CHRONOFLEX 8 FR 1 LUMEN HAD TO BE EXPLANTED. CATHETER WAS NOT INTACT. PT HAD TO BE SENT TO TERTIARY CARE CENTER FOR INTERVENTIONAL RADIOLOGY TO REMOVE CATHETER. SERIAL NO, MODEL/CAT NO: (B)(4), MFR: CR BARD / ACCESS SYSTEMS, IMPLANTED ON (B)(6) 2011, LOT REVE0991 #1808000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740221 IMPLANTABLE POWERPORT MRI AIRGUARD CHRONOFLEX PORT + CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEM, INC. 1808000 REVE0991

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization