BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6842977 · Received September 5, 2017

    Report

    Report Number
    1213809-2017-00091
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    July 31, 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

    A DHR REVIEW FOR LOT #7001794 AND #7001796 WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOTS WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THREE PHOTOS WERE RECEIVED BY BD CANAAN DEPICTING SAMPLES FROM EITHER BATCH #7001794 OR #7001796. THEY WERE EVALUATED FOR THE REPORTED DEFECTS. IN ONE OF THE SAMPLES, A PIECE OF RUBBER CAN BE SEEN HANGING FROM THE STOPPER. FM SPOTS WERE OBSERVED ON THE BARREL OF 3 OTHER SAMPLES. HOWEVER, THE PHOTOS WERE OF LOW RESOLUTION, SO IT WAS NOT POSSIBLE TO EVALUATE THE FM IN DETAIL TO IDENTIFY IT. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. 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.

    Additional Manufacturer Narrative · 1

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7001794; MEDICAL DEVICE EXPIRATION DATE: 12/31/2021; DEVICE MANUFACTURE DATE: 02/24/2017; MEDICAL DEVICE LOT #: 7001796; MEDICAL DEVICE EXPIRATION DATE: 12/31/2021; DEVICE MANUFACTURE DATE: 01/19/2017. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK SPOTS WERE FOUND AT THE BOTTOM OF THE BARREL, ON THE PLUNGER AND ON THE NECK OF A 5 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY. IN ADDITION, FOREIGN MATTER WAS FOUND INSIDE THE PLUNGER 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
    621177 5 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other