BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML L/T SSU NRFIT

    MDR report key: 20938563 · Received December 16, 2024

    Report

    Report Number
    1911916-2024-00915
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 25, 2024
    Report Date
    January 12, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    QEH
    UDI-DI
    00382904001834
    PMA / PMN Number
    K192538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E AND F CODE UPDATED: E2403 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. F26 - NO HEALTH CONSEQUENCES OR IMPACT. (B)(4) FOLLOW UP. IT WAS REPORTED THE SYRINGE LEAKS DURING FILLING AND USE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 400183 AND LOT NUMBER 4080028. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT 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. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED . NO PATIENT IMPACT.

    Description of Event or Problem · 0

    SYRINGE LEAKS WHEN FILLING AND DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2311858 SYRINGE 50ML L/T SSU NRFIT PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT QEH BECTON DICKINSON 4080028 00382904001834

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown