BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 21641419 · Received March 19, 2025

    Report

    Report Number
    1911916-2025-00208
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 3, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    00382903065950
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: IT WAS REPORTED THE FLUSHER WAS FOUND DAMAGED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS TWO SYRINGES OUT OF THE PACKAGING FLOW WRAP WITH THE SYRINGE BARREL FLANGE DAMAGED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION OCCURS IF THERE IS A JAM DURING THE PLUNGER ROD ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306595, LOT 4250009. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE SYRINGE PLUNGER ROD PROCESS WAS PERFORMED. THE SETTINGS AND ALIGNMENT OF THE INFEED SCROLL WERE CORRECT. THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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

    ON (B)(6) 2025, THE BD PRE-FILLED CATHETER FLUSHER WAS USED TO FLUSH THE PATIENT'S CATHETER. IT WAS FOUND THAT THE FLUSHER WAS DAMAGED, WHICH COULD EASILY CAUSE THE MEDICAL STAFF'S HANDS TO BE SCRATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690374 SYRINGE 10ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 4250009 00382903065950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown