BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK¿ SYRINGE

    MDR report key: 6843537 · Received September 5, 2017

    Report

    Report Number
    1213809-2017-00090
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    July 24, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE EVALUATION: ONE LOOSE 3ML ASSEMBLED SYRINGE WAS RECEIVED BY BD CANAAN AND REPORTED TO BE FROM BATCH #7030783 OR 7030784. THE SAMPLE WAS VISUALLY EVALUATED. THE SAMPLE ARRIVED WITH A TIP CAP THAT IS NOT A CANAAN PART AND HAD TO BE REMOVED TO LOCATE THE FM. LIGHT BROWN GREASE LIKE FM WAS OBSERVED AT THE TOP OF THE INSIDE BARREL COLLAR. BARREL MOLD C-234 CAVITY #21. MOLD TECHNICIANS EVALUATED THE SAMPLE. THE LIKELY ROOT CAUSE FOR GREASE ON THE INSIDE OF LUER IS PRESENCE OF GREASE ON THE THREAD CORE INSIDE THE MOLD. A DHR REVIEW WAS PERFORMED FOR LOT #¿S 7030783 AND 7030784. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BOTH LOTS WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. 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. BASED ON THE SAMPLE EVALUATION: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. THERE WAS A PRESENCE OF GREASE ON THE THREAD CORE INSIDE THE MOLD. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    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 THAT A BLACK SPOT WAS FOUND ON THE OUTSIDE PORTION OF A 3 ML BD LUER LOK¿ SYRINGE LIP. FOREIGN MATTER WAS FOUND PRIOR TO USE. NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620973 3 ML BD LUER-LOK¿ SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other