BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7331698 · Received March 12, 2018

    Report

    Report Number
    1213809-2018-00097
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    January 25, 2018
    Report Date
    March 14, 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

    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 STRIP OF 5 PACKAGED 1ML LL ASSEMBLED SYRINGES FROM BATCH #7030524 (309628) WAS DEPICTED IN THE PHOTOS. THE PACKAGES WERE SEALED AND HAD NEITHER BATCH NOR EXPIRATION DATE PRINTED ON THEM. THE DEFECT IS REJECTABLE PER PRODUCT SPECIFICATION. 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 (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE IS UNDETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRODUCTION, A PROCESS TECHNICIAN NOTICED THAT TEN BD LUER-LOK¿ 1ML SYRINGES WERE DELIVERED WITHOUT THE LOT # AND EXPIRATION DATE PRINTED ON THEM. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175825 1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7030524 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other