BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL CHINA SP

    MDR report key: 10237813 · Received July 6, 2020

    Report

    Report Number
    1911916-2020-00619
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 19, 2020
    Report Date
    June 30, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INVESTIGATION SUMMARY: NO SAMPLE OR PHOTO WAS PROVIDED FOR INVESTIGATION. WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. HOWEVER, THE INSPECTIONS PERFORMED WHILE PRODUCING THIS LOT WERE ALL ACCEPTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 9140780 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. BASED ON THE INVESTIGATION CARRIED OUT AND WITH NO SAMPLE FOR ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED. NO ADDITIONAL ACTIONS WILL BE TAKEN OTHER THAN MONITORING THE COMPLAINT TREND FOR THIS LOT. THIS LOT WAS PRODUCED FOR 1.38MM UNITS; THEREFORE, THE CPM IS 0.7. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION CARRIED OUT AND WITH NO SAMPLE FOR ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 5ML SALINE FILL CHINA SP EXPERIENCED A DAMAGED/BROKEN PLUNGER ROD WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, AFTER INFUSION WAS COMPLETED AT 19:00, WHEN THE NURSE SEALED THE TUBE FOR THE PATIENT, HE FOUND THAT THE STOPPER HANDLE OF BD FLUSH WAS DAMAGED, AND IMMEDIATELY REPLACED FOR THE CHILD AND REPORTED THE ADVERSE EVENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696837 SYRINGE 5ML SALINE FILL CHINA SP PREFILLED SALINE SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9140780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other