BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 1366348 · Received April 20, 2009

    Report

    Report Number
    1710034-2009-00068
    Event Type
    Other
    Date Received
    April 20, 2009
    Date of Event
    March 13, 2009
    Report Date
    March 18, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - RECEIVED 50 REPRESENTATIVE SAMPLES FOR THE INVESTIGATION. OUR QUALITY ENGINEER VISUALLY AND MICROSCOPICALLY INSPECTED THE RETURNED SAMPLES AND CONFIRMED THE SAMPLES MET MANUFACTURING SPECIFICATIONS. THE DEVICE HISTORY WAS REVIEWED FOR THE REPORTED LOT NUMBER AND NO IRREGULARITIES WERE NOTED DURING THE LOT'S MANUFACTURE. CONCLUSION - THE ENGINEER CONCLUDED THAT THE INVESTIGATION DID NOT CONFIRM FOR NEEDLE STICK INJURY OR NEEDLE RETRACTION FAILURE. NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES WITH THE PRODUCT RETURNED FOR EVAL. THE RETURNED PRODUCT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT REPORTED. CAPA #(B) (4) WAS OPENED TO DOCUMENT AND TRACK THE FOLLOWING CORRECTIVE ACTIONS: THE PRESSURE HOSES WERE INSPECTED/UPDATED AS NEEDED AND HOUSE PRESSURE WAS DEDICATED TO THE GEL STATION, THE GEL VALVES HAVE BEEN UPDATED TO LIMIT THE STROKE ON THE PISTON ON ALL LINES, THE TRAJECTORY OF THE GEL NOZZLE WAS CORRECTED TO ASSIST IN INSERTING THE GEL PLACEMENT TIP WITHIN THE HOLE OF THE GRIP, THE MACHINE CONTROLS (ALARMS) FOR THE GEL LINE PRESSURE SENSOR SETTINGS HAVE BEEN TIGHTENED, THE QUALITY CONTROL PLAN WAS TIGHTENED TO MONITOR THE GEL PROCESS MORE RIGOROUSLY AND CHECKS THE STABILITY OF THE GEL SYSTEM ON THE MANUFACTURING FLOOR EVERY 2 HOURS. IT ALSO TRACKS GEL WEIGHT DURING NORMAL PRODUCTION INSTEAD OF ONLY AT SET-UP FOR ALL FOUR GEL HEADS, AND ASSESS THE FINAL FREQUENCY OF THE CONTROL PLAN TO ENSURE ADEQUATE COVERAGE (SAMPLE SIZE & FREQUENCY) FOR THE GEL SYSTEM. (B) (4).

    Description of Event or Problem · 1

    NEEDLE FAILED TO RETRACT AND EXTRA CARE WAS NOT EXERCISED, AND A NEEDLE STICK INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 8301317

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR