BEUDAMED
    FDA Adverse Event Other Summary report: N

    STANDARD SPROTTE NEEDLE WITH INTRODUCER

    MDR report key: 642966 · Received October 24, 2005

    Report

    Report Number
    9611612-2005-00001
    Event Type
    Other
    Date Received
    October 24, 2005
    Date of Event
    September 27, 2005
    Report Date
    October 17, 2005
    Manufacturer
    PAJUNK GMBH
    Product Code
    BSP
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING THE INTRODUCER CANNULA THE HUB WENT OFF THE NEEDLE. THE NEEDLE STUCK IN PATIENTS BACK. THE NEEDLE WAS REMOVED WITH A MINIMAL SURGICAL INTERVENTION. ACCORDING TO THE DOCTOR, NO FURTHER TREATMENT IS NECESSARY. THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD SPROTTE NEEDLE WITH INTRODUCER STANDARD SPROTTE NEEDLE 19G WITH INTRODUCER BSP PAJUNK GMBH 321151-31C 630

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention