BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6749281 · Received July 27, 2017

    Report

    Report Number
    1213809-2017-00069
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    June 30, 2017
    Report Date
    September 8, 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DHR REVIEW FOR BATCH 7001785 (P/N (B)(4)): MANUFACTURING DATES: 1/03/17 - 1/05/17. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7001785 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE LOOSE 10ML ASSEMBLED SYRINGE WAS RECEIVED BY BD CANAAN AND REPORTED TO BE FROM BATCH #7001785 (P/N (B)(4)). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE MULTIPLE BLACK SPOTS LOCATED BETWEEN THE LUER AND BARREL ROOF EXTENDING TO THE FIRST MINOR GRAD LINE. THE SPECKS APPEAR TO BE DRIED INK OUTSIDE THE PRINT AREA AND NOT IN FLUID PATH. THEY ARE LEVEL 1 IN SIZE. THIS IS AN ACCEPTABLE CONDITION AT BD CANAAN AND IS CONSIDERED TO BE A COSMETIC DEFECT. BASED ON THE SAMPLE EVALUATION: UNCONFIRMED: BD (B)(4) WAS NOT ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. BASED ON THE FACT THAT NO REJECTABLE DEFECT WAS FOUND, CAPA IS NOT REQUIRED AT THIS TIME. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLACK SPOT WAS FOUND ON THE TIP OF A 5 ML BD LUER-LOK¿ SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529602 5 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7001785

    Patients

    Seq Age Sex Outcome Treatment
    1 Other