BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 8827435 · Received July 25, 2019

    Report

    Report Number
    1911916-2019-00729
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 11, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE (1) SAMPLE WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE SAMPLE WAS VISUALLY EXAMINED USING UNAIDED VISION AND NO SUBSTANCES WERE OBSERVED ON THE SYRINGE. AS THE CUSTOMER REPORTED A ¿STICKY SUBSTANCE ON THE SYRINGE¿ A TISSUE WAS LIGHTLY RUN OVER THE SYRINGE TO SEE IF ANY SUBSTANCES WERE DETECTED. NO SUBSTANCES WHICH CAUGHT THE TISSUE WERE DETECTED. BASED ON SAMPLE ANALYSIS THE CONDITION REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED AS NO SUBSTANCES WERE DETECTED ON THE BARREL SURFACE. 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: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER (FM) FOR LOT #9120506 ITEM #302832. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. ROOT CAUSE DESCRIPTION: BASED ON SAMPLE ANALYSIS THE CONDITION REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED AS NO SUBSTANCES WERE DETECTED ON THE BARREL SURFACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYRINGE 30ML LL S/C 56. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "1 ML SYRINGE HAS A WHITE POWDER SUBSTANCE AND THE 30ML SYRINGE HAS A STICKY SUBSTANCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623181 SYRINGE 30ML LL S/C 56 PISTON SYRINGE FMF BECTON DICKINSON AND COMPANY 9120506 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other