BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOMAGIC

    MDR report key: 2674804 · Received July 23, 2012

    Report

    Report Number
    2925153-2012-00005
    Event Type
    Other
    Date Received
    July 23, 2012
    Date of Event
    April 8, 2012
    Report Date
    July 22, 2012
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS ASSESSED AND DETERMINED NOT TO BE PRODUCT MANUFACTURED BY NEO MEDICAL, INC. INCLUDED IN THIS REPORT IS: PRODUCT LABEL FOR KIT (B)(4) (1.9FR SL PICC WITHOUT INTRODUCER). LETTER FROM DISTRIBUTOR (B)(4)STATING THAT THE DEVICE IN QUESTION WAS NOT SUPPLIED IN KIT (B)(4) AND WAS NOT MFG BY NEO MEDICAL. BASED ON THE INVESTIGATION THIS REPORT IS NOT APPLICABLE TO A DEVICE MANUFACTURED BY NEO MEDICAL AND CONSIDERED CLOSED.

    Description of Event or Problem · 1

    REPORT RECEIVED STATED PEEL AWAY SHEATH THAT IS REMOVED BY SNAPPING TWO WINGS TOGETHER, ONE WING BROKE OFF MAKING IT IMPOSSIBLE TO PEEL AWAY THE SHEATH. LINE NEEDED TO BE REMOVED. DEVICE IN QUESTION WAS SENT BACK TO THE DISTRIBUTOR ((B)(4)) TO PROVIDE THE MFR FOR EVAL. UPON REVIEW OF THE DEVICE AND PHONE CONVERSATION WITH MFR IT WAS NOTED BY (B)(4), SALES MGR THAT THE KIT IN QUESTION ((B)(4)) DOES NOT INCLUDE A PEEL-AWAY INTRODUCER AND THE DEVICE RECEIVED BY (B)(6) WAS NOT MFG BY NEO MEDICAL. DEVICE WAS RETURNED TO (B)(6) TO THE ATTENTION OF, (B)(6) FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOMAGIC 1.9FR SL PICC KIT FULL TRAY DQY NEO MEDICAL, INC. 1955-1615 1020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other