BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK (N35C)

    MDR report key: 8025106 · Received October 31, 2018

    Report

    Report Number
    3003152976-2018-00467
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 11, 2018
    Report Date
    December 3, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    50382905150055
    PMA / PMN Number
    K140591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR: N/A - NO LOT. 1 SAMPLE WAS EVALUATED BY JFR LAB. ACCORDING TO THEIR REPORT, THE GRIPS OF THE SAFETY SLEEVE WERE DAMAGED. THE INJECTOR COULD BE PROPERLY CONNECTED TO ANOTHER DEVICE. INSPECTIONS AND TESTS THE TESTS PERFORMED DURING THE MANUFACTURING PROCESS TO AVOID FAULTY PARTS ARE LISTED BELOW: DURING MOLDING PROCESS (ACCORDING PH-300 CURRENT VERSION): -VISUAL INSPECTIONS FOR INJECTOR PARTS (CYLINDER, NEEDLE HOUSING, SAFETY SLEEVE, PISTON AND MEMBRANE) ARE PERFORMED BY THE OPERATOR TO AVOID FAULTY PARTS (FLASHES, UNFILLED AND BURNED PARTS, ETC). -CRITICAL TO QUALITY DIMENSIONS OF ALL INJECTOR COMPONENTS ARE MEASURED TO CHECK IF THE DIMENSIONS ARE WITHIN TOLERANCE. ASSEMBLY PROCESS: (ACCORDING TO PH-301 CURRENT VERSION) THE FOLLOWING VISUAL INSPECTIONS ARE PERFORMED BY THE OPERATOR: -SAFETY SLEEVE MUST BE CONNECTED AND SHOULD BE TURNING WITH THE CYLINDER AND PISTON. THE FUNCTIONALITY OF THE GRIPS IS VERIFIED. -VERIFY THE CORRECT WELDING OF THE MEMBRANE, COLOR AND ASPECT. -CYLINDER ASSEMBLY. PISTON MUST BE FIXED BY THE SAFETY SLEEVE. -NEEDLE HOUSING SHOULD ROTATE CLOCKWISE AND TIP OF THE CANNULA MUST BE OBSERVED. -CANNULA LENGTH (WITH A CALIPER GAUGE). -FUNCTIONALITY AND PISTON WELDING TEST: QUALITY AND FUNCTIONALITY OF THE MEMBRANE IS VERIFIED AFTER BE WELDING AND PUNCTURED BY THE CANNULA. THE EXPOSURE OF THE NEEDLE IS CAUSED DUE TO THE BREAKAGE OF THE SAFETY SLEEVE. IT IS IMPORTANT TO HOLD ONTO THE WHITE PART OF THE INJECTOR BEFORE ENGAGING/DISENGAGING. DO NO TOUCH THE BLUE PART: * IF GRIPS OF THE SAFETY SLEEVE ARE REMOVED FROM THEIR PLACE, THE INJECTOR IS ACTIVATED CAUSING NEEDLE EXPOSURE. *THE INJECTOR MUST BE REMOVED PULLING IT BACK: IF IT IS REMOVED WITHOUT DOING THIS THE GRIPS ARE REMOVED FROM THEIR PLACE AND NEEDLE EXPOSURE HAPPENS. IF THE INJECTOR HAS BEEN FORCED WHILE ENGAGING, THE GRIPS CAN ALSO GET DAMAGED. IN THIS CASE, THE DAMAGE OF THE GRIPS IN THE SAMPLE CONFIRMS THAT THE NEEDLE COULD BE EXPOSED ACCORDING TO THE DESCRIPTION OF THE CUSTOMER. THE CUSTOMER EXPLAINS THAT THIS TOOK PLACE DURING THE ENGAGEMENT: THIS MEANS THAT THE INJECTOR WAS NOT PROPERLY HANDLING AND AS PREVIOUSLY EXPLAINED, THE INJECTOR WAS FORCED WHILE ENGAGING AND THE GRIPS WERE DAMAGED. THIS DEFECT IS NOT RELATED TO A MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK (N35C) WAS BROKEN AND THE NEEDLE WAS EXPOSED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK (N35C) WAS BROKEN AND THE NEEDLE WAS EXPOSED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862959 BD PHASEAL¿ INJECTOR LUER LOCK (N35C) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN 50382905150055

    Patients

    Seq Age Sex Outcome Treatment
    1 Other