BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL BNS

    MDR report key: 22149442 · Received June 5, 2025

    Report

    Report Number
    1213809-2025-00377
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    April 15, 2025
    Report Date
    July 31, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010733
    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. 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)- SUPPLEMENTAL MDR - STOPPER JAMMED / INSECURE. ONE PHOTO OF A 3 ML LUER LOCK SYRINGE WAS RECEIVED AND EVALUATED. THE IMAGE SHOWS THE STOPPER NOT PROPERLY SEATED ON THE PLUNGER ROD, WHICH MAY LEAD TO LEAKAGE AND AFFECT THE SYRINGE¿S FUNCTIONALITY. THIS CONDITION IS CONSIDERED NON-CONFORMING PER THE PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE OF THE INSECURE STOPPER AND RESULTING LEAKAGE IS ASSOCIATED WITH THE ASSEMBLY PROCESS. AS THE LOT NUMBER IS UNKNOWN, A DEVICE HISTORY RECORD (DHR) OR QUALITY NOTIFICATION (QN) REVIEW COULD NOT BE PERFORMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL BNS STOPPER WAS JAMMED / INSECURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 301073, BATCH#: UNKNOWN. RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT NUMBER(S): (B)(4), PRODUCT SKU: 26001 (DNQSYR 3ML L/L) VENDOR PART NO: 301073) 153245 (DNQSYRINGE 5ML LL BNS), VENDOR PART NO: 304656), LOT 4193557, PRODUCT LOT NUMBER: UNKNOWN. COMPLAINT DETAILS: ¿DATE OF EVENT: 4/15/2025. IT WAS REPORTED THAT SYRINGES 3ML AND 5ML ARE "FAILING AND THE MEDS ARE GOING UP INTO THE SYRINGE ABOVE THE PLUNGER SEAL". DUE TO THIS, A NEW DEVICE IS REQUIRED.¿

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762064 BD SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 50382903010733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown