BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 6842962 · Received September 5, 2017

    Report

    Report Number
    1213809-2017-00092
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    August 7, 2017
    Report Date
    December 3, 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

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. CUSTOMER PHOTOS WERE SUBMITTED. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: INVESTIGATION SUMMARY: SIX PHOTOS WERE RECEIVED BY BD (B)(4) AND EVALUATED. THE 5ML SYRINGES IN THE PHOTOS WERE REPORTED TO BE FROM EITHER BATCH #7001796 OR 7030796 (309703). HOWEVER, A SPECIFIC LOT NUMBER WAS COULD NOT BE IDENTIFIED FOR THIS COMPLAINT. TWO OF THE SAMPLES HAVE THE CYLINDER IMAGE BLACK DOT BETWEEN 2ML AND 3ML GRADUATION MARKS. THESE ARE PART OF THE PRINT CYLINDER IMAGE AND ARE NOT DEFECTS. FOUR OF THE SAMPLES HAVE UNIDENTIFIABLE SMALL FM SPOTS ON THE BARREL NEAR THE FLANGE. DUE TO THE LOW RESOLUTION OF THE PHOTOS RECEIVED, THE FM COULD NOT BE EVALUATED IN DETAIL AND IDENTIFIED. DHR REVIEW FOR BATCH #7001796: ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7001796 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7030796: MANUFACTURING DATES: ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7030796 WAS 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. CONCLUSION: BASED ON THE SAMPLE EVALUATION, BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK SPOTS WERE FOUND ON THE MIDDLE OF THE BARREL, ON THE BOTTOM OF THE BARREL AND ON THE PLUNGER OF THE BARREL OF A 5 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY. 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
    621098 5 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other