BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 24443449 · Received February 25, 2026

    Report

    Report Number
    9614033-2026-00018
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 28, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903046577
    PMA / PMN Number
    N/A
    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

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TWO PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. BASED ON THE PHOTOS ALONE, IT WAS NOT POSSIBLE TO IDENTIFY ANY DAMAGE OR CRACKS ON THE LUER. THE REPORTED INCIDENT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 10ML LL BNS LUER WAS CRACKED / DAMAGED / DEFORMED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DEFECT DESCRIPTION: SYRINGE BROKE DURING USE PART #: 153239 PRODUCT DESCRIPTION: SYRINGE 10ML LL BNS VENDOR PART #: 304657 LOT #: 5020045 DATE REPORTED: 1/29/2026 SAMPLE RECEIVED: YES CUSTOMER RESPONSE ON 17-FEB-2026. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 01-28-2026 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM WAS REPORTED BASED ON THE INFORMATION PROVIDED, A SAMPLE IS AVAILABLE FOR EVALUATION. COULD YOU KINDLY SHARE THE ADDRESS OF THE FACILITY FOR US TO SEND THE SHIPPING LABEL? SAMPLE WAS BIOHAZARDOUS CUSTOMER RESPONSE ON 19-FEB-2026. I APOLOGIZE FOR THE MISCOMMUNICATION. THE SAMPLE WAS NOT RETAINED BECAUSE IT WAS BIOHAZARDOUS. I HAVE BEEN TOLD THAT BIOHAZARD SAMPLES ARE NOT RECEIVED BY BD, CAN YOU PLEASE CONFIRM FOR THE FUTURE IF BIOHAZARD SAMPLES ARE RECEIVED? SEE BELOW RESPONSE: CAN YOU GIVE FURTHER DESCRIPTION ON THE EVENT? PER CUSTOMER SYRINGE ¿CRACKED NEAR THE TOP¿. WHERE DID THE SYRINGE BREAK? BASED ON SAMPLE EVALUATION THE DAMAGE WAS AT THE TIP OF SYRINGE. WERE THERE ANY VISIBLE CRACKS OR DAMAGE TO SYRINGE? YES, SMALL CRACK NOTED AT THE TIP WAS A LEAK NOTED? YES WHEN WATER WAS PUSHED THROUGH, IT SQUIRTED OUT OF THE CRACK.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120498 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 5020045 00382903046577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other