BEUDAMED
    FDA Adverse Event Other Summary report: N

    5FR. DL POWER-V

    MDR report key: 2211368 · Received August 4, 2011

    Report

    Report Number
    2925153-2011-00013
    Event Type
    Other
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 29, 2011
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    LJS
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ASSESSED AND DETERMINED TO BE AN MDR REPORTABLE EVENT BASED ON OUR MDR REPORTING CRITERIA. F/U REPORT WILL BE PROVIDED UPON THE COMPLETION OF THE DEVICE EVAL PROCESS. PRODUCT AND LOT # IS BEING VERIFIED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED IN E-MAIL FROM (B)(6) DIRECTOR PT SAFETY AND RISK MANAGEMENT (B)(6). AN INCIDENT REPORTED ON (B)(6) THAT INVOLVED A DEFECTIVE PICC LINE, WAS REMOVED BY IV THERAPY. THE PICC DEVELOPED A HOLE AND THE OTHER LUMEN HAD A WEAKNESS THAT BALLOONED OUT LIKE AN ANEURYSM. THERE WAS NO ADVERSE PT OUTCOME AND THE LINE HAD BEEN MANAGED APPROPRIATELY AT SPAULDING NORTH SHORE. THE LINE WAS INSERTED AT BETH ISRAEL HOSPITAL ON (B)(6). THE PRODUCT INFO IS BEING VERIFIED, LOT HISTORY AND PRODUCT CATALOG # DO NOT MATCH OUR RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5FR. DL POWER-V POWER-V CATH LJS NEO MEDICAL, INC. 5068-2660 1036

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention