BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL BNS

    MDR report key: 17992809 · Received October 23, 2023

    Report

    Report Number
    1213809-2023-01172
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 3, 2023
    Report Date
    January 25, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010733
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) ¿ FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED PART OF THE SCALE IS MISSING ON THE SYRINGE. TO AID IN THE INVESTIGATION, TWENTY-TWO SAMPLES AND THREE PHOTOS OF A 3ML LUER LOK SYRINGE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ALL THE SAMPLES WERE RECEIVED LOOSE AND HAVE MARKS ON MULTIPLE MINOR GRADUATION LINES CAUSING A VOID IN THE PRINT. THE THREE PHOTOS PROVIDED SHOW THE LOOSE SYRINGES WITH THE SAME CONDITIONS AS THE SYRINGES RECEIVED. AS THE GRADUATION LINES CONTAIN MORE THAN 75% OF THE PRINT, THE CONDITION OBSERVED DOES NOT AFFECT FORM, FIT OR FUNCTION AND IS ACCEPTABLE PER PRODUCT SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301073, LOT 2223871. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 2223871 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN, SUBSEQUENTLY APPROVED FOR SHIPMENT AND IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL BNS HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MISSING PART OF THE SCALE ON SYRINGE - INCORRECT SCALE ON THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140688 BD SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2223871 50382903010733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown