BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAMAX PLUS UNIVERSAL PROCEDURE TRAY

    MDR report key: 1651588 · Received April 1, 2010

    Report

    Report Number
    1625685-2010-00009
    Event Type
    Injury
    Date Received
    April 1, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 31, 2010
    Manufacturer
    CAREFUSION
    Product Code
    KIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE ACTUAL COMPLAINT SAMPLE CONFIRMED THE COAXIAL SLEEVE HAD BROKEN APPROX 1 CM BELOW THE UB OF THE ASSEMBLY. INSPECTION OF THE BREAK IN THE SLEEVE NOTED THE SHEER AREA WAS BENT SUGGESTING THE SLEEVE CANNULA WAS BENT PRIOR TO THE BREAK. THE ACTUAL SOURCE OF THE BENT OR RESULTING BREAK COULD NOT BE IDENTIFIED BY THE COMPLAINT INVESTIGATION. THEREFORE; BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. THE LOCATION AND NATURE OF THE BREAK SUGGESTS THAT THE COAXIAL SLEEVE WAS BENT PRIOR TO USE, BUT THE INVESTIGATION WAS UNABLE TO DETERMINE THE POTENTIAL SOURCE. A DEVICE HISTORY REVIEW, RAW MATERIAL HISTORY FILES FOR THE LISTED MFG LOTS SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. A REVIEW OF APPLICABLE MFG PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE IDENTIFIED FAILURE MODE. ALL APPLICABLE MFG AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS FAILURE MODE IN AN EFFORT TO HEIGHTEN AWARENESS AND MINIMIZE ANY IMPACT FROM THE MFG PROCESS.

    Description of Event or Problem · 1

    NEEDLE STYLET BROKE IN HALF IN PT WHILE DOCTOR WAS INSERTING CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAMAX PLUS UNIVERSAL PROCEDURE TRAY AVAMAX PLUS UNIVERSAL PROCEDURE TRAY KIH CAREFUSION VMX00CT LPK313

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other