BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 24547676 · Received March 9, 2026

    Report

    Report Number
    1911916-2026-00107
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 28, 2026
    Report Date
    March 5, 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

    IT WAS REPORTED THAT A CATHETER WITH A DAMAGED, LEAKING WALL WAS DISCOVERED. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE PROVIDED TO THE QUALITY TEAM. THE IMAGES SHOW A SYRINGE WITHOUT ITS FLOW WRAP PACKAGING. A CRACK IS VISIBLE NEAR THE MID SECTION OF THE SYRINGE BARREL, WITH SOLUTION LEAKAGE AT THE CRACK SITE. THIS CONDITION COULD OCCUR IF A JAM WERE TO OCCUR DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306595, LOT 5140925. THE REVIEW IDENTIFIED NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE ISSUED. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE ASSEMBLY PROCESS CONFIRMED CORRECT ALIGNMENT OF THE RAILS AND CONVEYORS, AND PRODUCT FLOW WAS SATISFACTORY. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, INCLUDING ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE, THE CUSTOMER¿S REPORTED CONDITION IS CONFIRMED.

    Description of Event or Problem · 0

    A DAMAGED AND LEAKING CATHETER WALL WAS DISCOVERED DURING CATHETER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611334 SYRINGE 10ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 5140925 00382903065950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown