BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRI LOW PROFILE PORT WITH ATTACHABLE 7 FR GROSHONG SINGLE-LUM

    MDR report key: 1854550 · Received September 28, 2010

    Report

    Report Number
    3006260740-2010-00272
    Event Type
    Death
    Date Received
    September 28, 2010
    Date of Event
    July 29, 2010
    Report Date
    September 2, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJT
    PMA / PMN Number
    K924250
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVAL. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT IMPLANTED WITH BARD PORT ON (B)(6) 2010 BY IR. AS THE HOSPITAL DID NOT LEAVE ANY PORT IMPLANT RELATED MEDICAL RECORD, WE CANNOT FIND LOT NUMBER INFO. NURSE CANNOT DRAW BLOOD BACK FROM PT THROUGH HUB NEEDLES ON (B)(6). CT IMAGE SHOW CATHETER FALL OFF AND THE CATHETER FRAGMENT WAS BETWEEN INFERIOR VENA CAVA AND HEPATIC VEIN. IR TOOK OUT BROKEN CATHETER ON (B)(6) AND FIND THE CATHETER TIP IS COMPLETE, ANOTHER BROKEN END LIKE SAW TOOTH. PHYSICIAN TOOK OUT PORT ON AUG 10 AND SAW 1 TO APPROXIMATELY 2 MM BROKEN CATHETER ATTACHED WITH PORT STEM. PT DIED DUE TO LUNG THROMBOSIS IN WEEK (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRI LOW PROFILE PORT WITH ATTACHABLE 7 FR GROSHONG SINGLE-LUM LJT C. R. BARD INC. (BASD) RETD0066

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death