BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3CC 25X1 MAGELLAN SAFETY COMBO

    MDR report key: 4190489 · Received October 21, 2014

    Report

    Report Number
    1017768-2014-00028
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    August 11, 2014
    Report Date
    October 13, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT HISTORY RECORDS IS NOT POSSIBLE WITHOUT A LOT NUMBER. MAINTENANCE RECORDS (BOTH CORRECTIVE AND PREVENTIVE) AND CALIBRATION RECORDS CANNOT BE REVIEWED WITHOUT A LOT NUMBER. A REVIEW OF THE PROCESS MONITORING DATA CANNOT BE DONE WITHOUT A LOT NUMBER. A SAMPLE WAS RETURNED WITH THIS COMPLAINT. VISUAL EXAMINATION OF THE SAMPLE SHOWED THAT THE CANNULA WAS BENT APPROXIMATELY 20 DEGREES TO THE OPPOSITE SIDE OF THE THUMB REST. THE BEND OCCURRED AT THE TOP OF THE EPOXY MOUND. THE ISSUE REPORTED BY THE CUSTOMER IS CONFIRMED. A STIFFNESS TEST OF THE SAMPLE CANNULA WAS PERFORMED PER PROCEDURE. THE SAMPLE WAS FOUND TO BE WITHIN SPECIFICATION. A CHECK OF THE OUTSIDE DIAMETER (OD) OF THE SAMPLE WAS PERFORMED AND THE SAMPLE WAS WITHIN SPECIFICATION. A VISUAL EXAMINATION WITH 7X MAGNIFICATION LOUPE WAS PERFORMED BY THE QUALITY ENGINEER TO DETECT ANY POTENTIAL MOLDING ISSUES THAT COULD PREVENT THE SHIELD FROM PERFORMING AS INTENDED. NO ISSUE WAS FOUND WITH THE MOLDED HUB OR SHIELD. THE EXACT ROOT CAUSE OF THE BENT CANNULA REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IT IS UNLIKELY THAT THIS BENDING OF THE CANNULA WOULD OCCUR DURING THE MANUFACTURE PROCESS BECAUSE THE NEEDLE SHIELD AND SHEATH WOULD NOT LOAD ON A BENT CANNULA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT A CUSTOMER HAD AN ISSUE WITH A SAFETY NEEDLE. THE CUSTOMER REPORTS THE NEEDLE BENT DURING USE. THE NEEDLE BENT COMING OUT OF PATIENT THEREFORE THE SAFETY MECHANISM WOULD NOT ACTIVATE. THE CUSTOMER STATED THAT IF THEY WOULD NOT HAVE NOTICED IT, THEY WOULD HAVE BEEN STUCK BY THE NEEDLE. THE CUSTOMER CONFIRMED THAT THEY HAD DONE NOTHING OUT OF THE ORDINARY TO CAUSE THE NEEDLE TO BEND, IT WAS UTILIZED PROPERLY.

    Description of Event or Problem · 1

    THE MOST LIKELY ROOT CAUSE IS IF DURING USE, THE USER PUSHED THE THUMB REST AGAINST THE CANNULA INSTEAD OF PUSHING IT FORWARD. ACCORDING TO THE INSTRUCTIONS FOR USE, UNDER STEP 7, IMMEDIATELY FOLLOWING THE INJECTION OR ASPIRATION PROCEDURE, LOCK THE SAFETY NEEDLE SHIELD USING ANY OF THE FOLLOWING METHODS: PUSH THE SAFETY SHIELD FORWARD IN A SINGLE-HANDED MANNER TO COVER THE NEEDLE AND LOCK THE SHIELD. KEEP YOUR FINGER OR THUMB BEHIND THE NEEDLE TIP AT ALL TIMES. OR PRESS THE SAFETY SHIELD, LEVER SIDE DOWN ONTO A FLAT SURFACE TO COVER THE NEEDLE AND LOCK THE SHIELD, I.E., BEDSIDE TABLE. PRIOR TO A LOT'S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, ALL LOTS OF NEEDLE TUBING ARE TESTED FOR STIFFNESS IN ACCORDANCE WITH ISO STANDARD 9626, "STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES". THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS. THE PRODUCTION DEPARTMENT WILL BE NOTIFIED OF THIS INCIDENT WITH A COPY OF THIS COMPLAINT RESPONSE. THIS COMPLAINT WILL BE RECORDED FOR TRACKING AND TRENDING PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668071 3CC 25X1 MAGELLAN SAFETY COMBO SAFETY NEEDLE FMI COVIDIEN 8881833510 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1