BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWER-V PICC 5

    MDR report key: 1644570 · Received March 26, 2010

    Report

    Report Number
    2925153-2009-00007
    Event Type
    Other
    Date Received
    March 26, 2010
    Date of Event
    October 23, 2009
    Report Date
    March 18, 2010
    Manufacturer
    NEOMEDICAL, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT NUMBER: 1008A. THIS REPORT WAS ASSESSED WHEN RECEIVED AND NO MDR REPORT WAS THE DECISION. A REVIEW WAS CONDUCTED AFTER AN FDA AUDIT AND THE DECISION WAS MADE TO SUBMIT THIS REPORT. NO USED SAMPLE WAS MADE AVAILABLE DESPITE REQUESTS. INFO / DATA ON MURAL THROMBOSIS SHOWS THAT: IT OCCURS WITH A HIGH DEGREE OF FREQUENCY WITH IMPLANTS. IT CAN BE CAUSED BY VARIOUS FACTORS AND NOT NECESSARILY THE CATHETER. THE PRODUCT IFU INDICATES THAT THIS IS A POSSIBLE COMPLICATION.

    Description of Event or Problem · 1

    THE REPORT RECEIVED ON (B)(6) 2009 STATED IN SUMMARY: IN (B)(6) 2009, 8 PICCS IMPLANTED HAD COMPLICATIONS BECAUSE OF MURAL THROMBOSIS. THEY REALIZED ABOUT THIS PROBLEM AFTER 10 DAYS FROM THE IMPLANTATION OF EVERY OF THESE 8 PICCS. THE PICCS ARE 6 FROM LOT 1007 AND 2 FROM LOT 1008A. INTERVENTION IN THE FORM OF FLUOROSCOPY AND 'MEDICAL' WERE NEEDED. THE PT IS STABLE. NO PRODUCT SAMPLE WAS RETAINED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER-V PICC 5 V-CATH LJS NEOMEDICAL, INC. 5025-160 1007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention