BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35J

    MDR report key: 7684466 · Received July 12, 2018

    Report

    Report Number
    3003152976-2018-00285
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 19, 2018
    Report Date
    August 15, 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: ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON INSPECTION OF THE RETURNED SAMPLE, NO DEFECTS WERE OBSERVED AND LEAKAGE DID NOT OCCUR IN THE MEMBRANE. AS A LOT NUMBER IS UNKNOWN FOR THIS INCIDENT ADDITIONAL RETAINED SAMPLES COULD NOT BE INVESTIGATED AND A PRODUCTION REVIEW COULD NOT BE PERFORMED. THE TESTS PERFORMED DURING THE MANUFACTURING PROCESS TO AVOID FAULTY PARTS ARE LISTED BELOW: DURING MOLDING PROCESS: 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: 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 PENETRATED BY THE CANNULA. POSITIVE PRESSURE TEST IS PERFORMED ACCORDING TO PC-225 TO VERIFY THE PROPERLY WELDING OF THE SEALING AS WELL. RESULTS OF THIS TEST HAVE BEEN ACCEPTABLE (> 180 N). FOR ALL MANUFACTURED LOTS, LEAKAGE TEST IS PERFORM ACCORDING TO PC-226. CONCLUSION: NO LEAK OR OTHER DEFECT WAS FOUND IN SAMPLE EVALUATED BY JFR LAB. BASED ON THE INVESTIGATION, A CAUSE FOR THE REPORTED DEFECT COULD NOT BE ESTABLISHED. BASED ON THE ACCEPTABLE RESULTS FOR THE SAMPLE TESTED IT WAS DETERMINED THAT NO CAPA IS REQUIRED.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF A BD PHASEAL¿ INJECTOR LUER LOCK N35J THE "DRUG LEAKED FROM N35." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF A BD PHASEAL¿ INJECTOR LUER LOCK N35J THE "DRUG LEAKED FROM N35." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 THAT DURING USE OF A BD PHASEAL¿ INJECTOR LUER LOCK N35J THE "DRUG LEAKED FROM N35." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525864 BD PHASEAL¿ INJECTOR LUER LOCK N35J INJECTOR ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other