BEUDAMED
    FDA Adverse Event Other Summary report: N

    PICC

    MDR report key: 1504909 · Received October 9, 2009

    Report

    Report Number
    2925153-2009-00006
    Event Type
    Other
    Date Received
    October 9, 2009
    Date of Event
    August 17, 2009
    Report Date
    October 9, 2009
    Manufacturer
    NEOMEDICAL, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECTED CATHETER IS A SILICONE CATHETER AND THE IFU GIVES CLEAR DIRECTIONS AND ADVICE CONCERNING SECUREMENT AND OTHER USE OF THE PRODUCT. THE USED SAMPLE HAS NOT BEEN MADE AVAILABLE. FOLLOW UP CONTACT HAS BEEN MADE AND MORE INFORMATION AND THE SAMPLE ID ANTICIPATED.

    Description of Event or Problem · 1

    THE INITIAL VERBAL REPORT, RECEIVED ON (B)(6) 2009, STATED THE PICC WAS INSERTED (B)(6) 2009 AND HAD TO BE REMOVED BECAUSE IT WAS BROKEN AT THE CONNECTION SITE BETWEEN THE CATHETER AND THE BUTTERFLY WING DEVICE. NO OTHER INFORMATION HAS BEEN RECEIVED TO DATE. THE E-MAIL REPORT STATES "I HAVE NOT RECEIVED ANY OTHER CONCERNS FROM FHA CLINICIANS". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC V-CATH LJS NEOMEDICAL, INC. UNK 1055

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention