BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRI PLASTIC PORT WITH ATTACHABLE 8 FR GROHSONG CATHETER - INTROD

    MDR report key: 1980140 · Received February 1, 2011

    Report

    Report Number
    3006260740-2011-00032
    Event Type
    Death
    Date Received
    February 1, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 19, 2011
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJT
    PMA / PMN Number
    K873213
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    THE CATHETER BREAK WAS FOUND. THE INDWELLING PERIOD WAS 364 DAYS. INFUSION DIFFICULTIES HAVE BEEN EXPERIENCED PRIOR TO THE INCIDENT. ATTEMPT WAS MADE TO RETRIEVE DISTAL PORTION OF CATHETER WITH SNARE. THE CATHETER WAS FOUND TO BE EMBEDDED IN THE VESSEL AND COULD NOT BE REMOVED. DECISION WAS MADE TO LEAVE CATHETER IN THE BODY. IT WAS REPORTED THAT THE PT HAS SINCE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRI PLASTIC PORT WITH ATTACHABLE 8 FR GROHSONG CATHETER - INTROD LJT C.R. BARD, INC. (BASD) RERJ0125

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death