BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 24293042 · Received February 9, 2026

    Report

    Report Number
    1911916-2026-00061
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    February 1, 2026
    Report Date
    February 20, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    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

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION: BATCH NUMBER UNKNOWN. SEE B TAB. (B)(4) FOLLOW UP. IT WAS REPORTED THAT THE PLUNGER ASSEMBLY FRACTURED. TO SUPPORT THE INVESTIGATION, A SINGLE PHOTOGRAPH WAS RECEIVED AND EVALUATED BY THE QUALITY TEAM. THE PHOTOGRAPH DEPICTS AN EMPTY SYRINGE WITHOUT PACKAGING FLOW WRAP OR A TIP CAP. THE SYRINGE BARREL FLANGE IS DAMAGED, AND NO OTHER DEFECTS OR IMPERFECTIONS ARE EVIDENT. THIS CONDITION COULD OCCUR IF THE INFEED SCROLL WERE MISALIGNED DURING THE PLUNGER ROD ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306595, COVERING POSSIBLE LOTS 5140925 AND 5070175. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE SYRINGE PLUNGER ROD ASSEMBLY PROCESS WAS PERFORMED, THE INFEED SCROLL SETTINGS AND ALIGNMENT WERE CORRECT, AND PRODUCT FLOW WAS ACCEPTABLE. BASED ON THE INVESTIGATION AND THE PHOTO ANALYSIS, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A PATIENT WITH INTESTINAL TUMOR RECEIVED A NUTRITIONAL INFUSION AS PRESCRIBED. AFTER THE INFUSION CONCLUDED, WHILE USING A PREFILLED SYRINGE TO FLUSH THE CATHETER AND CLOSE IT, THE PLUNGER ASSEMBLY FRACTURED. THE NURSE IMMEDIATELY REPLACED THE SYRINGE WITH A NEW PREFILLED SYRINGE TO COMPLETE THE PROCEDURE. THE INCIDENT DID NOT CAUSE HARM TO THE PATIENT.

    Description of Event or Problem · 0

    UNKNOWN LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355950 SYRINGE 10ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 00382903065950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown