BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL CE

    MDR report key: 8735309 · Received June 26, 2019

    Report

    Report Number
    1911916-2019-00631
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 6, 2019
    Report Date
    June 10, 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
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED; IT CAME IN A (B)(6) PLASTIC BAG. THE PLUNGER ROD HAS BEEN REMOVED FROM THE SYRINGE AND THE RUBBER STOPPER IS AT 5ML. THE SALINE SOLUTION IS UP TO THE 3ML MARK. THE BARREL LABEL CONFIRMS THE LOT# 8201717. THE PLUNGER ROD WAS ASSEMBLED BACK AND SCREWED TO THE RUBBER STOPPER. THE RETAINING RING WORKED HOLDING THE PLUNGER ROD. ROOT CAUSE IS UNDETERMINED. 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: THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 8201717 DURING THE PRODUCTION RUN. THIS IS THE 1ST COMPLAINT FOR THE LOT# 8201717 FOR THE SAME DEFECT OR SYMPTOM. ROOT CAUSE DESCRIPTION: ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 5ML SALINE FILL CE EXPERIENCED A PLUNGER THAT WAS LOOSE/FELL OUT PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531506 SYRINGE 5ML SALINE FILL CE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8201717

    Patients

    Seq Age Sex Outcome Treatment
    1 Other