BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML S/T BNS

    MDR report key: 22983256 · Received September 5, 2025

    Report

    Report Number
    1213809-2025-00581
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    May 20, 2025
    Report Date
    August 22, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010283
    PMA / PMN Number
    NA
    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

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. FIFTY SAMPLES OF 5 ML LUER-SLIP SYRINGES WERE RECEIVED AND EVALUATED. ALL SAMPLES WERE LOOSE WITHIN TWO SEPARATE BAGS OF TWENTY-FIVE, EACH LABELED WITH A DIFFERENT BATCH. BATCH 5078135 CONTAINED EIGHTEEN DEFECT-FREE SAMPLES AND SEVEN WITH MAJOR PLUNGER ROD DAMAGE. BATCH 5062523 HAD FIFTEEN DEFECT-FREE SAMPLES, TEN WITH THE STOPPER JAMMED BETWEEN THE BARREL AND PLUNGER ROD, AND ONE WITH A BROKEN BARREL TIP. DROPLETS WERE OBSERVED ON THE ROOF OF MOST BARRELS, WITH NO STRINGING OR POOLING. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS ON ONE SAMPLE FROM EACH BATCH CONFIRMED THE DROPLETS TO BE SILICONE USED IN THE MANUFACTURING PROCESS. THE OBSERVED CONDITIONS ARE NON-CONFORMING PER PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE FOR THE PLUNGER ROD DAMAGE AND STOPPER JAMMED DEFECTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS. SILICONE IS APPLIED AS A SPRAY OF PARTICLES TO THE INSIDE OF THE BARREL. IT IS UNCLEAR WHAT TYPE OF STORAGE AND HANDLING CONDITIONS THE PRODUCT WAS SUBJECTED TO AFTER LEAVING THE MANUFACTURING PLANT. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 25 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 30 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. PLEASE REFER TO THE ATTACHED SILICONE QUANTITY GUIDELINE FOR REFERENCE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 5078135 AND 5062523. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML S/T BNS HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #301028. LOT #5078135, 5062523. IT WAS REPORTED BY CUSTOMER THAT FM NONCONFORMANCES WITH *BD301028*SYRINGE:5ML-SLIP-TIP. VERBATIM: HELLO¿. (B)(6), PRODUCTION JUST NOTIFIED ME OF MORE FM NONCONFORMANCES WITH *BD301028*SYRINGE:5ML-SLIP-TIP** THE FOLLOWING LOT NUMBERS: XXXX MANUFACTURING IS SENDING BACK TO XXXX IQC. THERE ARE 4 DIFFERENT LOTS THIS TIME. 2541110.1 QTY (B)(4). 2536995.1 QTY (B)(4). 2544338.1 QTY (B)(4). 2550363.1 QTY (B)(4). XXXXXX COMPLAINTS-HAVE YOU IDENTIFIED THE ROOT CAUSE TO THIS ISSUE? COMPLAINT # (B)(4). ADDITIONAL INFORMATION PROVIDED: 1. AS YOU MENTIONED, ALL ITEMS ARE AFFECTED BY FOREIGN MATTER. COULD YOU PLEASE SPECIFY WHERE THE FOREIGN MATTER WAS FOUND? WAS IT WITHIN THE FLUID PATHWAY? YES, THE FOREIGN MATTER IS LOCATED WITHIN THE FLUID PATHWAY, ALONG WITH OTHER AREAS OF THE UNITS. 2. THE TRACKING INFORMATION FOR THE PROVIDED SHIPPING LABEL STILL SHOWS THE INITIAL LOCATION. COULD YOU PLEASE LET US KNOW WHEN THE SAMPLE IS EXPECTED TO BE SHIPPED? THE SAMPLES WILL BE SHIPPED OUT TOMORROW MORNING, 12JUN2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265689 BD SYRINGE 5ML S/T BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5062523 50382903010283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown