BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL

    MDR report key: 23129492 · Received September 23, 2025

    Report

    Report Number
    1213809-2025-00616
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 11, 2025
    Report Date
    September 25, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP REPORT FOR CORRECTION. THIS COMPLAINT WAS FOUND TO BE A DUPLICATE OF PR (B)(4) AFTER THE MDR WAS SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL PLUNGER ROD WAS BROKEN /DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305060 BATCH # 5150321. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC XXX AND XXX ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO ITEM: 305060 QUANTITY AFFECTED: 3 EA SERIAL/LOT NUMBER: (B)(6), PO : (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: ON (B)(6) PER CST XXX: ON THREE OCCASION REGISTERED NURSE NOTICE THE 3 ML SYRINGE WERE DEFEATED. THE RNS REPORTS THE PLUNGERS BROKE IN HALF DURING ADMINISTRATION OF THE MEDICATION. THIS CAUSE THE BARREL TO LINK THE MEDICATION PRIOR TO GIVING AN INJECTION. NO HARM CAME TO THE PATIENT. EXP DATE - 4/30/2030.

    Description of Event or Problem · 0

    (B)(4) IS A DUPLICATE COMPLAINT AND WILL BE CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210016 BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5150321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown