BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD LUER-LOK¿ SYRINGE

    MDR report key: 7059836 · Received November 27, 2017

    Report

    Report Number
    1213809-2017-00313
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 26, 2017
    Report Date
    January 23, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS. DHR REVIEW FOR BATCH 7030524 (P/N 309628): MANUFACTURING DATES: 02/04/2017 TO 02/05/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7030524 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: TWO PHOTOS WERE RECEIVED BY BD (B)(4) AND EVALUATED. A SINGLE PACKAGED 1ML LL ASSEMBLED SYRINGE FROM A REPORTED BATCH #166901 (309628) WAS DEPICTED IN THE PHOTOS. THE PACKAGE WAS SEALED AND HAD NEITHER BATCH NOR EXPIRATION DATE PRINTED ON IT. THIS IS A REJECTABLE DEFECT. CONCLUSIONS: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. UNDETERMINED - BASED ON THE INVESTIGATION RESULTS TO DATE, ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A QA PART CHECK, A 1 ML BD LUER-LOK¿ SYRINGE WAS FOUND WITHOUT AN EXPIRATION DATE PRINTED ON THE COMPONENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841009 1 ML BD LUER-LOK¿ SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7030524 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other