BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CE

    MDR report key: 8853384 · Received August 1, 2019

    Report

    Report Number
    1911916-2019-00765
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 26, 2019
    Report Date
    August 1, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED. IT SHOWS A SYRINGE WITH THE PACKAGING FLOW WRAP. THE FLOW WRAP HAS A PIECE OF RED TAPE. THIS RED TAPE IS A SPLICE COMING FROM THE PACKAGING FLOW WRAP INDICATING THE END OF THE PACKAGING. A DEFECTIVE SAMPLE WAS CREATED, THE SENSOR WAS CHALLENGED; THE SENSOR REJECTED THE DEFECTIVE SAMPLE. ROOT CAUSE WAS THE PACKAGING FLOW WRAPPER AND FAILURE OF AN EMPLOYEE TO STOP THIS SAMPLE FROM GETTING THROUGH. 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. 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 # 8200566 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: ROOT CAUSE WAS THE PACKAGING FLOW WRAPPER AND FAILURE OF AN EMPLOYEE TO STOP THIS SAMPLE FROM GETTING THROUGH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 10ML SALINE FILL CE EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING IS DIFFERENT FROM THE OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647416 SYRINGE 10ML SALINE FILL CE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8200566

    Patients

    Seq Age Sex Outcome Treatment
    1 Other