BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35J

    MDR report key: 7584771 · Received June 8, 2018

    Report

    Report Number
    3003152976-2018-00243
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 29, 2018
    Report Date
    June 26, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: LEAK BETWEEN INJECTOR AND CONNECTION. THE SAMPLES (1 INJECTOR + 2 PROTECTORS) WERE EVALUATED BY JFR LAB. ACCORDING TO ITS REPORT (RECEIVED ON JUN 25TH 2018), NO DEFECTS WERE FOUND. - NO LEAK WAS CONFIRMED (NO LEAK AT THE MEMBRANE, NO LEAK THROUGH HYDROPHOBIC FILTER, NO LEAK BETWEEN THE INJECTOR AND THE PROTECTORS). 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 CALLIPER GAUGE). - FUNCTIONALITY AND PISTON WELDING TEST: QUALITY AND FUNCTIONALITY OF THE MEMBRANE IS VERIFIED AFTER BE WELDING AND PUNCTURED BY THE CANNULA. INVESTIGATION CONCLUSION: BASED ON REPORT RECEIVED, THERE IS NO EVIDENCE TO CONFIRM THE DEFECT: NO LEAK WAS FOUND. AS THE LOT THE UNKNOWN, DHR CANNOT BE CHECKED. IT IS RECOMMENDED TO CAREFULLY FOLLOW THE INSTRUCTIONS EXPLAINED IN THE IFU OF INJECTORS AND PROTECTORS.

    Additional Manufacturer Narrative · 1

    NO LOT # PROVIDED. 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 DURING USE A BD PHASEAL¿ INJECTOR LUER LOCK N35J WAS FOUND LEAKING AS "WHEN PREPARING CISPLATIN IN THE SAFETY CABINET, DRUG LEAKED FROM THE JOINT". THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426908 BD PHASEAL¿ INJECTOR LUER LOCK N35J INJECTOR ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other