BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 22561985 · Received July 21, 2025

    Report

    Report Number
    1213809-2025-00490
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    July 8, 2025
    Report Date
    August 5, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - PLUNGER ROD BROKEN / DAMAGED. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BATCH 5023063 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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.

    Additional Manufacturer Narrative · 0

    H.3. 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 WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 200 S/C PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309657. LOT #5023063. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CHC COMPLAINT REFERENCE #: (B)(4). HOSPITAL COMPLAINT REFERENCE #: (B)(4). CORRESPONDENCE LANGUAGE: ENGLISH. CAT# OF PRODUCT BEING COMPLAINED: BD309657. DESCRIPTION OF PRODUCT: SYRINGE LL TIP ST 3CC 200EA/BX 4BX/CA. LOT OR S/N: (B)(6) COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE. REPORTABLE: NO. INCIDENT DATE: (B)(6) 2025. HOSPITAL COMPLAINT REFERENCE #: (B)(4). DETAILS OF COMPLAINT (REPORTED ISSUE): CLINICIAN USING SYRINGE WHEN PLUNGER OF SYRINGE BROKE INTO TWO PIECES. ADDITIONAL INFORMATION WILL BE SENT VIA SEPARATE EMAIL. COMPLAINT NOTICED: DURING / AFTER USE. PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: PATIENT INJURY: NO. HAS HEALTH CANADA BEEN INFORMED? UNKNOWN. QTY AFFECTED: (B)(4). SAMPLES AVAILABLE? NO. IS CUSTOMER REQUESTING AN RGA? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766701 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5023063 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown