BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL NS

    MDR report key: 23220865 · Received October 6, 2025

    Report

    Report Number
    3003152976-2025-00556
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 29, 2025
    Report Date
    December 17, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: BASED ON THE FACT THAT THE DEFECT COULD NOT BE REPRODUCED IN THE RETAINED SAMPLES, AND THE CUSTOMER DID NOT PROVIDE ANY SAMPLE OR PHOTO FOR THE INVESTIGATION, THE DEFECT CANNOT BE CONFIRMED. ADDITIONALLY, SINCE THE DHR REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCE OR INCIDENT RELATED TO THE DEFECT, THE ROOT CAUSE CANNOT BE CONFIRMED WITHIN OUR PROCESS. 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 QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. INITIAL MDR, IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    EVENT DETAILS: DEFECT DESCRIPTION: SYRINGES ARE FAULTY - BURST OR CRACKED ALONG THE BARREL DURING USE, DESPITE NO EXCESSIVE PRESSURE BEING APPLIED PART #: 153239 / 153238 . PRODUCT DESCRIPTION: SYRINGE 10ML LL BNS / SYRINGE 20ML LL NS VENDOR PART #: 304657 / 302055. LOT #: 4319005 / 2501002 . DATE REPORTED: 8/25/2025 TO DISTRIBUTOR SAMPLE RECEIVED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340145 SYRINGE 20ML LL NS SYRINGE, PISTON FMF BECTON DICKINSON, S.A. 2501002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown