BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUCATH

    MDR report key: 1722480 · Received June 14, 2010

    Report

    Report Number
    1020279-2010-00159
    Event Type
    Injury
    Date Received
    June 14, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 18, 2010
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    BSP
    PMA / PMN Number
    K091818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.THE MEDICAL FACILITY INVOLVED HAS DECLINED TO RETURN THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    DURING MANIPULATION AND INSERTION ATTEMPTS, THE TIP OF THE DEVICE SHEARED OFF AND WAS NOT RETRIEVABLE FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUCATH SPINAL INJECTION SYSTEM BSP BROOKS MANUFACTURING SITE 09MMT0001

    Patients

    Seq Age Sex Outcome Treatment
    1