BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER-V PICC 5 FR SINGLE LUMEN

    MDR report key: 1874485 · Received October 15, 2010

    Report

    Report Number
    2925153-2009-00013
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    October 23, 2009
    Report Date
    October 13, 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

    ADDITIONAL LOT #: 1008A. THE ORIGINAL 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 A REPORT. NO USED SAMPLE WAS MADE AVAILABLE DESPITE REQUESTS. INFORMATION/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. BASED ON FDA ADVICE, THIS MDR IS BEING PREPARED TO ADDRESS THE FACT THAT THE ORIGINAL COMPLAINT RELATED TO EIGHT (8) EACH CATHETERS. THE OTHER RELATED MDR FILES ARE NUMBERED AS FOLLOWS: 5.1 NEO 2925153-2009-00007 (THE ORIGINAL REPORT), 5.2 NEO 2925153-2009-00012, 5.3 NEO 2925153-2009-00013 (THIS REPORT), 5.4 NEO 2925153-2009-00014, 5.5 NEO 2925153-2009-00015, 5.6 NEO 2925153-2009-00016, 5.7 NEO 2925153-2009-00017, AND 5.8 NEO 2925153-2009-00018. ALSO, BASED ON FDA ADVICE, ALL EIGHT REPORTS WILL BE CATEGORIZED AS "SERIOUS INJURY".

    Description of Event or Problem · 1

    THE ORIGINAL REPORT RECEIVED ON 10/23/2009, 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 PATIENT IS STABLE. NO PRODUCT SAMPLE WAS RETAINED. THE ORIGINAL REPORT WAS FILED AS AN MDR AND THIS REPORT IS DISCUSSED OVER LEAF AT "ADDITIONAL MANUFACTURER NARRATIVE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER-V PICC 5 FR SINGLE LUMEN V-CATH LJS NEOMEDICAL, INC 5025-1660 1007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention