BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35J

    MDR report key: 8400176 · Received March 7, 2019

    Report

    Report Number
    3003152976-2019-00192
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 15, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    UDI-DI
    00382905150081
    PMA / PMN Number
    N/A
    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: A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. BROKEN SAFETY SLEEVE THE SAMPLE WAS EVALUATED BY JFR LAB: VISUAL INSPECTION SHOWS THE NEEDLE EXPOSED. VISUAL INSPECTION SHOWS THE TIP DAMAGED. THE NEEDLE IS BENT. 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. CONCLUSION: THE BREAKAGE OF THE SAFETY SLEEVE OCCURS WHEN THE INJECTOR IS NOT PROPERLY DISENGAGED. IN THIS CASE, THE NEEDLE WAS ALSO DAMAGED DUE TO THE WRONG HANDLING. IF THE NEEDLE WAS BADLY ASSEMBLED DURING THEM MANUFACTURING PROCESS, THE INJECTOR WOULDN¿T BE FUNCTIONAL AND COULDN¿T BE ATTACHED TO OTHER DEVICE. SO, THIS OPTION IS DISCARDED. THE DEFECT SEEMS TO BE CAUSED BY A MISUSE BY THE CUSTOMER. HOWEVER, CAPA 708467 WAS OPEN PRIOR TO THE INVESTIGATION OF THIS COMPLAINT TO ASSESS THE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PREPARING ENDOXAN TO BE USED WITH A BD PHASEAL¿ INJECTOR LUER LOCK N35J, IT HAD AN EXPOSED NEEDLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREPARING ENDOXAN TO BE USED WITH A BD PHASEAL¿ INJECTOR LUER LOCK N35J, IT HAD AN EXPOSED NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195577 BD PHASEAL¿ INJECTOR LUER LOCK N35J PHASEAL ADMINISTRATION SET LHI BECTON DICKINSON, S.A. UNKNOWN 00382905150081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other