BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIAL CATH BAR TYPE E

    MDR report key: 2210349 · Received August 9, 2011

    Report

    Report Number
    1226348-2011-00300
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT ONE PIECE OF CATHETER WAS RETURNED AND WAS VISUALLY INSPECTED, ONE END IS CLEAN CUT, AND THE TAPERED END IS JAGGED. AS NOTED IN THE COMPLAINTS DESCRIPTION THE DEVICE BROKE DURING SURGERY, IT IS POSSIBLE THAT THE BREAKAGE COULD HAVE BEEN ATTRIBUTED TO CUSTOMER HANDLING. THIS HOWEVER COULD NOT BE CONFIRMED. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY AND WHEN IT WAS REMOVED, THEY NOTICED THE TIP HAS SHEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIAL CATH BAR TYPE E SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC., MEDOS S.A. NA CJCDM1

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR