BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.9 FR PICC

    MDR report key: 1479393 · Received September 16, 2009

    Report

    Report Number
    2925153-2009-00004
    Event Type
    Other
    Date Received
    September 16, 2009
    Date of Event
    June 28, 2009
    Report Date
    September 17, 2009
    Manufacturer
    NEOMEDICAL, INC
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 1.9 FR CATHETER IS A SILICONE CATHETER AND THE IFU GIVES CLEAR DIRECTIONS AND ADVICE CONCERNING THE USE OF THE PRODUCT. THE USED SAMPLE WAS MADE AVAILABLE. IT HAS BEEN RETURNED TO NEOMEDICAL, AND HAS BEEN SENT FOR STERILIZATION PRIOR TO HANDLING AND EXAMINATION.

    Description of Event or Problem · 1

    THE INITIAL VERBAL REPORT, RECEIVED ON (B)(6) 2009, STATED PICC BROKE DUE TO IMPROPER SECUREMENT. FOLLOW UP INFORMATION STATED "THE INFANT HAD A SAPHENOUS LINE. WHEN THE INFANT WRAPPED ITS OPPOSITE FOOT AROUND THE LINE IT SNAPPED INTO 2 PIECES." THE TWO PIECES WERE RETRIEVED AND NO OTHER INTERVENTION WAS NEEDED. THERE WAS NO PATIENT SEQUELAE; THE PATIENT IS STABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.9 FR PICC V-CATH / NEOMAGIC DQO NEOMEDICAL, INC 1941-1640 1012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention