BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD LUER-LOK¿ SYRINGE

    MDR report key: 6849972 · Received September 7, 2017

    Report

    Report Number
    1213809-2017-00098
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 1, 2017
    Report Date
    November 10, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOR BATCH 7031844 (P/N 302995): MANUFACTURING DATES: 3/4/17 ¿ 3/5/17. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7031844 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: TWO 10ML SYRINGES IN OPENED PACKAGES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7031844 (P/N 302995). THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE LIGHT SILICONE VISIBLE ON THE INSIDE OF THE SYRINGE. THE SILICONE WAS NOT STRINGING OR POOLING. THE AMOUNT OBSERVED WAS A NORMAL AND EXPECTED AMOUNT OF SILICONE FOR THIS PRODUCT PER PRODUCT SPECIFICATION. THE SMALL AMOUNT IS REQUIRED FOR THE PRODUCT TO FUNCTION PROPERLY. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. NO CAPA NECESSARY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE, THERE WAS A STICKY SUBSTANCE IN THE BARREL OF THE 10 ML BD LUER-LOK¿ SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630405 10 ML BD LUER-LOK¿ SYRINGE SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other