BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 24469921 · Received February 27, 2026

    Report

    Report Number
    1213809-2026-00095
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 11, 2026
    Report Date
    April 9, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096497
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. SIX SAMPLES OF 10 ML EUROGRAPHIC SYRINGES, PART NUMBER 309649, WERE RECEIVED AND EVALUATED, WITH TWO SAMPLES EACH FROM BATCHES 5072216, 5280258, AND 5309031. ALL SAMPLES ARRIVED IN UNSEALED PACKAGING AND SHOWED NO DEFECTS. SILICONE WAS VISIBLE ON THE STOPPERS, HOWEVER, THERE WAS NO EVIDENCE OF STRINGING OR POOLING, INDICATING THAT THE AMOUNT WAS NOT EXCESSIVE AND MET PRODUCT SPECIFICATIONS. SILICONE IS AN INERT, NON-TOXIC MEDICAL LUBRICANT THAT IS AN INTEGRAL COMPONENT OF DISPOSABLE SYRINGES, ENSURING PROPER PERFORMANCE IN CLINICAL USE. THIS CONDITION DOES NOT IMPACT PRODUCT SAFETY, EFFICACY, OR FUNCTIONALITY. SILICONE HAS BEEN USED IN THIS APPLICATION FOR OVER 25 YEARS, WITH MORE THAN 30 BILLION UNITS DISTRIBUTED AND NO KNOWN REPORTS OF ADVERSE CLINICAL EFFECTS RELATED TO UNINTENDED SILICONE DELIVERY. PLEASE REFER TO THE ATTACHED SILICONE QUANTITY GUIDELINE FOR ADDITIONAL DETAILS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT NUMBERS 5072216, 5280258, AND 5309031. THE REVIEW IDENTIFIED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION.

    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

    IT WAS REPORTED THAT BD SYRINGE 5ML LL EURO 125 S/C CONTAINED VISIBLE SILICONE. IT LOOKS LIKE MOISTURE OR SOMETHING ELSE AND THE PHARMACY IS NOT SURE TO PREPARE MEDICATION WITH THESE SYRINGES. THE CUSTOMER SAID, IT SEEM´S LIKE MOISTURE, BUT SHE DON'T KNOW IT. THE LIQUID WAS SEEN ABOVE THE PLUNGER AND INSIDE THE SYRINGE BODY. THE SAMPLES ARE ON THE WAY AND WILL BE EXAMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304809 BD SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5072216 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other