BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL CHINA SP

    MDR report key: 8875137 · Received August 8, 2019

    Report

    Report Number
    1911916-2019-00784
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 24, 2019
    Report Date
    July 31, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED. TWO SYRINGES ARE SHOWN IN THE PHOTO. ONE HAS BARREL LABEL AND THE OTHER ONE HAS NO BARREL LABEL. BOTH ARE WITHOUT THE PACKAGING FLOW WRAP. BOTH HAVE THE PLUNGER ROD-RUBBER STOPPER, TIP CAP, AND SOLUTION. FAILURE MODE IS VERIFIED. THIS WOULD HAVE OCCURRED DUE TO AN ISSUE WITH THE PLUNGER ROD LABELER MACHINE. 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 FIRST COMPLAINT FOR THE LOT# 8141911 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH # 8141911 DURING THIS PRODUCTION RUN. ROOT CAUSE DESCRIPTION: ROOT CAUSE PLUNGER ROD LABELER MACHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML SALINE FILL CHINA SP LABEL WAS MISSING. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT 1EA FLUSH LABEL MISSING WHEN OPENING THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671136 SYRINGE 5ML SALINE FILL CHINA SP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8141911

    Patients

    Seq Age Sex Outcome Treatment
    1 Other