BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER LOK¿ SYRINGE

    MDR report key: 7165255 · Received January 4, 2018

    Report

    Report Number
    1213809-2017-00431
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 13, 2017
    Report Date
    March 13, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095729
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: A PHOTO AND A QUICKTIME VIDEO WERE RECEIVED BY BD (B)(4) AND EVALUATED. THE VIDEO SHOWED A 3ML SYRINGE FROM DIFFERENT ANGLES. THE BARREL OF THE SYRINGE APPEARED TO HAVE A MOLDING DEFECT LIKELY ORIGINATING IN THE CORE OF THE CAVITY OF THE MOLD WHICH RESULTED IN SUCH APPEARANCE OF THE PLASTIC. A DEVICE HISTORY RECORD (DHR) REVIEW FOR BATCH 7121991 (P/N 309572) WAS PERFORMED, ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7121991 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. BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, A BD LUER LOK¿ SYRINGE WAS FOUND WITH FOREIGN MATERIAL. IT WAS REPORTED ¿WHEN THE SYRINGES WERE FELT THEY WERE ALMOST ETCHED WITH EXTRA OIL ON THE INSIDE.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10335 BD LUER LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7121991 30382903095729

    Patients

    Seq Age Sex Outcome Treatment
    1 Other