BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL BNS

    MDR report key: 23677058 · Received November 30, 2025

    Report

    Report Number
    9614033-2025-00120
    Event Type
    Malfunction
    Date Received
    November 30, 2025
    Date of Event
    October 16, 2025
    Report Date
    March 12, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE PHOTOGRAPH DOES NOT ALLOW DETERMINING THE LOCATION OF THE OBSERVED OBJECT IN RELATION TO THE PRODUCT OR ITS PACKAGING, NOR ESTABLISHING ITS ORIGIN. A PHYSICAL SAMPLE WAS ALSO NOT PROVIDED SO DETERMINATION OF WHAT THE FOREIGN MATTER WAS COULD NOT BE COMPLETED. THE REPORTED INCIDENT COULD NOT BE VERIFIED. THE REVIEW OF THE ENVIRONMENTAL MONITORING RECORDS FOR THE BATCH UNDER INVESTIGATION SHOWS NO EVENTS OR DEVIATIONS IN VIABLE OR NON-VIABLE PARTICLE RESULTS, NOR IN THE PEST CONTROL PROGRAM, WITH ALL VALUES REMAINING WITHIN ESTABLISHED LIMITS. ADDITIONALLY, THE DOCUMENT REVIEW DID NOT IDENTIFY ANY QUALITY INCIDENTS SIMILAR TO THE REPORTED DEFECT DURING THE MANUFACTURING STAGES OF THE PRODUCT. IT IS IMPORTANT TO NOTE THAT THE PROCESS INCLUDES VALIDATED CLEANING AND SANITIZATION CONTROLS, AS WELL AS PERSONNEL ENTRY CONTROL PROCEDURES, WHICH MITIGATE THE INTRODUCTION OF FOREIGN MATERIALS INTO THE PRODUCTION AREAS. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 20ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 304658, BATCH#: 5049600. IT WAS REPORTED BY CUSTOMER THAT BUG IN SYRINGE. RCC RECEIVED A COMPLAINT VIA EMAIL. MEDLINE COMPLAINT #: (B)(4), DEFECT DESCRIPTION: BUG IN SYRINGE, MEDLINE PART#: 153240, PRODUCT DESCRIPTION: SYRINGE 20ML LL NS, VENDOR PART#: 304658, LOT#: 5049600, DATE REPORTED: 10/16/2025, SAMPLE RECEIVED: NO, RESPONSE NEEDED: INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 1423395-2025-00186. NOTED BEFORE USE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: WHERE THE BUG WAS? IN THE BARREL? IN THE PACKAGING? WITHIN THE BARREL. ARE THERE ANY PHOTOS OF THE BUG BEFORE IT WAS REMOVED? NO. COULD IT BE SOMETHING ELSE SUCH AS CARDBOARD? WE DID NOT RECEIVE A SAMPLE, SO BASED ON THE PHOTO PROVIDED IT WAS CONFIRMED TO BE A BUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445837 BD SYRINGE 20ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 5049600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown