BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 24086277 · Received January 15, 2026

    Report

    Report Number
    2243072-2026-00016
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    October 2, 2025
    Report Date
    January 20, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    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

    D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AS NO PHYSICAL OR PICTURE SAMPLE, OR VALID LOT NUMBER WAS PROVIDED FOR EVALUATION, BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: UNKNOWN, BATCH#: UNKNOWN. RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT NUMBER(S): (B)(4), PRODUCT SKU: COMPONENT NO 26001 (DNOSYR 3ML L/L), COMPONENT NO: 153239 (DNOSYRINGE 10ML LL BNS,) COMPONENT NO: 153245 (DNQSYRINGE 5ML LL BNS), PRODUCT LOT NUMBER: UNKNOWN (DNOSYR 3ML L/L), 4193528 (DNOSYRINGE 10ML LL BNS), 4193540 (DNQSYRINGE 5ML LL BNS). COMPLAINT DETAILS: ¿ACCORDING TO THE FACILITY, ON (B)(6) 2025, DURING A PROCEDURE, IT WAS NOTICED THAT THE SYRINGE HAD HOLES IN IT CAUSING MEDICATION TO LEAK IN THE TRAY. PER THE FACILITY, THERE WAS NO PATIENT INVOLVEMENT OR INJURY RELATED TO THE INCIDENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION AT THIS TIME. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195072 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown