BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRI SINGLE LUMEN ACCESS

    MDR report key: 6357 · Received August 31, 1993

    Report

    Report Number
    6357
    Event Type
    Malfunction
    Date Received
    August 31, 1993
    Date of Event
    July 23, 1993
    Report Date
    October 7, 1993
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON OR ABOUT 8/3/93, A REPORT WAS SENT RELATED TO AN INCIDENT WITH AN IMPLANTED VASCULAR ACCESS DEVICE. AT THE TIME OF SUBMISSION THE INITIAL INFO, HAD NO SPECIFIC IDENTIFYING INFO AS TO TYPE OF ACCESS DEVICE OR DETAILED INFO SUCH AS LOT OR PRODUCT NUMBERS. AFTER SHOWING THE DEVICE TO A SURGEON WHO HAS EXTENSIVE EXPERIENCE WITH THESE TYPES OF DEVICES, RPTR WAS ABLE TO GAIN ADD'L INFO. THE PHYSICIAN IN QUESTION IDENTIFIED THE DEVICE AS AN MRI SINGLE LUMEN ACCESS DEVICE MFG BY BARD ACCESS SYSTEMS. ON 9/1/93, RPTR CONTACTED BARD ACCESS SYSTEMS TO ALERT THEM TO THE PROBLEMS WITH THE DEVICE. RPTR SPOKE WITH A FIELD ASSURANCE REP. AGAIN RPTR COULD ONLY GIVE HER BASIC INFO ABOUT THE DEVICE UNTIL RPTR WAS ABLE TO FURTHER IDENTIFY SPECIFIC MODEL AND LOT NUMBER. RPTR SUBSEQUENTLY RECEIVED INFO FROM AN OUTSIDE INSTITUTION WHO STATED THAT ACCORDING TO THEIR RECORDS THIS PARTICULAR DEVICE WAS IMPLANTED 10/7/91. AS RPTR HAS BEEN UNABLE TO REACH THE PT IN QUESTION BY PHONE, RPTR IS FORWARDING A LETTER TO HER TO REQUEST PERMISSION TO SEND THE DEVICE BACK TO THE MFR PRIOR TO ULTIMATELY RETURNING IT TO HER. AT THIS POINT, THEREFORE, THERE HAS BEEN NO MFR'S EVAL OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRI SINGLE LUMEN ACCESS MRI SINGLE LUMEN ACCESS LJT BARD ACCESS SYSTEMS UNKNOWN 36EB5140

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other