BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 1373622 · Received April 28, 2009

    Report

    Report Number
    1710034-2009-00075
    Event Type
    Other
    Date Received
    April 28, 2009
    Date of Event
    April 3, 2009
    Report Date
    April 3, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - RECEIVED 50 REPRESENTATIVE UNITS IN SEALED PACKAGING. OUR QUALITY ENGINEER VISUALLY AND MICROSCOPICALLY INSPECTED THE RETURNED UNITS AND FOUND NO MECHANICAL/PHYSICAL DAMAGE TO THE SPRING, NEEDLE HUB, GRIP, ANY MISSING COMPONENTS OR EVIDENCE OF GLUE ON THE BUTTON OR HUB. MANUALLY ROTATED THE CATHETER TIPS 360 DEGREES, THE CATHETERS DID COME OFF. THE UNITS DID RETRACT, WHEN THE BUTTON WAS DEPRESSED. THE DEVICE HISTORY WAS REVIEWED FOR THE REPORTED LOT UMBER AND NO IRREGULARITIES WERE NOTED DURING THE LOT'S MANUFACTURE. CONCLUSIONS - THE ENGINEER CONCLUDED THAT A ROOT CAUSE ANALYSIS COULD NOT BE DETERMINED, AS THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. THE RETURNED UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER REPORTED. CAPA (B) (4) WAS OPENED TO DOCUMENT AND TRACK THE CORRECTIVE ACTIONS BELOW: THE PLUMBING OF PRESSURIZED AIR WAS REVIEWED. THE PRESSURE HOSES WERE INSPECTED/UPDATED AS NEEDED AND HOUSE PRESSURE WAS DEDICATED TO THE GEL STATION. WORN OR DAMAGED PUMP SEALS AND GASKETS WERE REPLACED. THE GEL VALVES WERE 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 FOR THE GEL LINE PRESSURE SENSOR SETTINGS HAVE BEEN TIGHTENED. THE QUALITY CONTROL PLAN WAS TIGHTENED UNDER TEMPORARY DEVIATION ON DECEMBER 21, 2008. THIS WILL MONITOR THE GEL PROCESS MORE RIGOROUSLY AND CHECKS THE STABILITY OF THE GEL SYSTEM ON THE MANUFACTURING FLOOR EVERY TWO HOURS. IT ALSO TRACKS GEL WEIGHT DURING NORMAL PRODUCTION INSTEAD ON ONLY AT SET-UP FOR ALL FOUR GEL HEADS. OPERATOR TRAINING WAS COMPLETED IN JANUARY 2009. CORRECT DOCUMENTATION OF GEL WEIGHT MEASUREMENTS AND PROPER REACTION PLAN WILL BE ADDRESSED FOR OUT OF SPECIFICATION/ACTION LIMITS FOR GEL WEIGHTS. (B) (4). (B) (4).

    Description of Event or Problem · 1

    THE NURSE WAS TRYING TO GET THE NEEDLE OUT TO RETRACT, AND IT WOULD NOT. IT FELL FROM HER HAND AND STUCK HER.

    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 8358345

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK