BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 22937150 · Received September 2, 2025

    Report

    Report Number
    1911916-2025-00628
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 4, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903010318
    PMA / PMN Number
    K110771
    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

    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) FOLLOW UP: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 301031 AND LOT NUMBER 5153591. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT SIMILAR ISSUES DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: MATERIAL: 301031, BATCH: 5153591, PER THE CUSTOMER "OUR PHYSICIANS RAISED CONCERNS TODAY REGARDING THE 20ML SYRINGES THAT CAME IN OUR CATH LAB PACK. BLOOD IS SEEPING PAST THE PLUNGER WHEN BEING DRAWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075513 SYRINGE 20ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON 5153591 00382903010318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown