BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ L CONNECTOR C90J

    MDR report key: 7555413 · Received May 30, 2018

    Report

    Report Number
    3003152976-2018-00208
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    May 9, 2018
    Report Date
    June 7, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER COMPLAINTS ABOUT LEAKAGE. THE SAMPLE WAS EVALUATED BY JFR LAB. ACCORDING TO ITS REPORT, THE DEFECT IS CONFIRMED. THE LEAK OCCURS DUE TO THE BREAKAGE OF THE CONNECTOR. IN ORDER TO COMPLETE THE INVESTIGATION, TWO RETAINED SAMPLES WERE TAKEN AND NO DEFECTS WERE FOUND. THE CONNECTOR MAY HAVE BEEN BROKEN DURING A JAM IN THE PACKAGING MACHINES, CUT BY THE BLADES. HOWEVER, NO MAINTENANCES INTERVENTIONS WERE RECORDED IN DHR, NO NON-CONFORMANCES FOUND. BASED ON THE INFORMATION ABOVE, THE ROOT CAUSE CANNOT BE CLEARLY ESTABLISHED. INSPECTIONS AND TESTS IN MANUFACTURING AREA FOR PROTECTORS: VISUAL INSPECTIONS AND CRITICAL DIMENSIONS FOR C90 HOUSING PART ARE PERFORMED IN MOLDING AREA. (PH-300 CURRENT VERSION). VISUAL INSPECTIONS FOR PROTECTOR AND MEMBRANE ARE PERFORMED BY THE OPERATOR. BURRS, UNFILLED PARTS, PARTICLES, DIRTY, BURNED PARTS, INCORRECT COLOR, ETC. CRITICAL TO QUALITY DIMENSIONS OF ALL PROTECTORS HOUSING ARE MEASURED (8 INJECTIONS/8 HOURS). SPIKE INTERNAL DIAMETER (GO/NO GO GAUGE). SPIKE BASE EXTERNAL DIAMETER (GO/NO GO CAPILER GAUGE). ASSEMBLY PROCESS: (ACCORDING TO PH-305): IT IS A MANUALLY ASSEMBLY PROCESS, 100% OF THE PARTS ARE VISUALLY INSPECTED. THE FOLLOWING INSPECTIONS ARE PERFORMED FOR CONNECTOR C90: VISUAL INSPECTION: CORRECT WELDING OF THE MEMBRANE. MEMBRANE WELDING TEST IS PERFORMED WITH A CURETTE TO VERIFY THE CORRECT WELDING OF THE MEMBRANE. CORRECT LOCATION OF THE MEMBRANE IN THE CONNECTOR HOUSING CAVITY. VERIFY THAT WELDING BURRS DON´T EXCEED THE TOLERANCE. PARTS NOT DIRTY. SPIKE TIP WITHOUT DAMAGE. AUTOMATIC INSPECTION: MEMBRANE: NO WELDING OF THE MEMBRANE IN THE HOUSING, NO WELDING OF THE HOUSING AND NO MEMBRANE, WELDING HOUSING WITHOUT MEMBRANE, SKEWED MEMBRANE, UPSIDE DOWN MEMBRANE, DIRTY, ETC. LEAKAGE BETWEEN MEMBRANE AND CONNECTOR HOUSING. LEAKAGE TEST THROUGH PHASEAL MEMBRANE IS PERFORMED ACCORDING TO PC-226. INVESTIGATION CONCLUSION: THE CONNECTOR IS BROKEN. THE CONNECTOR MAY HAVE BEEN BROKEN DURING A JAM IN THE PACKAGING MACHINES, CUT BY THE BLADES. HOWEVER, NO MAINTENANCES INTERVENTIONS WERE RECORDED IN DHR, NO NON-CONFORMANCES FOUND. BASED ON THE INFORMATION ABOVE, THE ROOT CAUSE CANNOT BE CLEARLY ESTABLISHED.

    Additional Manufacturer Narrative · 1

    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 WHEN CONNECTING A BD PHASEAL¿ L CONNECTOR C90J TO THE INFUSION BAG AND INJECTING OXALIPLATIN, THE DRUG LEAKED FROM THE CRACK OF THE DEVICE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394678 BD PHASEAL¿ L CONNECTOR C90J CHEMOTHERAPY ADMINISTRATION SET LHI BECTON DICKINSON, S.A. 1706109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other