BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL BNS

    MDR report key: 18026656 · Received October 28, 2023

    Report

    Report Number
    1213809-2023-01186
    Event Type
    Malfunction
    Date Received
    October 28, 2023
    Date of Event
    October 6, 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
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) ¿ FOLLOW UP MDR FOR DEVICE EVALUATION IT WAS REPORTED THERE WAS A STOPPER PROBLEM. TO AID IN THE INVESTIGATION, ONE LOOSE 3ML LUER LOK SYRINGE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE WAS OBSERVED TO HAVE A JAMMED STOPPER THAT WAS LIKELY THE RESULT OF THE DAMAGED PLUNGER ROD TIP ALSO OBSERVED ON THE SAMPLE. THE CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4), 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. THESE CONDITIONS ARE OCCURRING AT OR BELOW THEIR EXPECTED FREQUENCY; THEREFORE, NO CORRECTIVE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 3ML LL BNS STOPPER WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "AS AGREED, AT THE END OF THE BATCH WE REPORT THE DISCREPANCIES FOUND. ALL REPORTS WERE DISCOVERED DURING PACKAGING, I.E. BEFORE USE. NO PATIENTS INVOLVED. " STOPPER PROBLEM X 1.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727008 SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2223871 50382903010733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown