BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL NS

    MDR report key: 24300081 · Received February 9, 2026

    Report

    Report Number
    3003152976-2026-00058
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    December 26, 2025
    Report Date
    April 16, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903020553
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTION, THE PLUNGER ROD IS OBSERVED TO BE BROKEN IN HALF. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURE, INCLUDING VERIFICATION THE PRODUCT IS FREE FROM DAMAGE. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. ADDITIONAL TESTING WAS PERFORMED USING A LOT FROM THE SAME MATERIAL. THE PRODUCT WAS BENT AND SUBJECTED TO EXTREME FORCE IN AN ATTEMPT TO REPLICATE THE OBSERVED FAILURE; HOWEVER, NO BREAKAGE OCCURRED. THE AREAS WHERE PIECES MOVE WITHIN THE EQUIPMENT ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT. BASED ON THE AVAILABLE INFORMATION, AND WITHOUT THE PHYSICAL SAMPLE TO FURTHER EVALUATION, A ROOT CAUSE RELATED TO THE PRODUCT OR MANUFACTURING PROCESS CANNOT BE ESTABLISHED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 20ML LL NS PLUNGER ROD WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 302055 BATCH#: UNKNOWN VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING SYRINGE BREAKING DURING USE. PLEASE SEE THE BELOW DETAILS REGARDING THE REPORTED ISSUE. IF IT IS INDICATED THAT A SAMPLE IS AVAILABLE, PLEASE PROVIDE SHIPPING INSTRUCTIONS WITHIN 30 DAYS OR THE SAMPLE WILL BE DISPOSED OF. COMPLAINT #: (B)(4). DEFECT DESCRIPTION: SYRINGE BREAKING DURING USE PART #: 153238 PRODUCT DESCRIPTION: SYRINGE 20ML LL NS VENDOR PART #: (B)(4). LOT #: UNKNOWN DATE REPORTED: 12/29/2025 SAMPLE RECEIVED: NO RESPONSE NEEDED: YES - INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 1423395-2026-00009 PLEASE REFERENCE THE ABOVE COMPLAINT NUMBER IN ALL FUTURE COMMUNICATIONS. IF YOU HAVE QUESTIONS OR NEED ADDITIONAL INFORMATION PLEASE REACH OUT . ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 26-12-2025 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO INJURY, MEDICAL INTERVENTION, OR OTHER ADVERSE HEALTH IMPACT WAS REPORTED PLEASE FOLLOW UP AND VERIFY: WAS THE SYRINGE IN USE WITH A PUMP OR BEING USED MANUALLY? IS THE LOT INFORMATION AVAILABLE? --------------------- ADDITIONAL FOLLOW-UP 1 SENT: -UNFORTUNATELY WE DO NOT HAVE FURTHER INFORMATION REGARDING THE BELOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158189 BD SYRINGE 20ML LL NS PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN 00382903020553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown