BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL CHINA SP

    MDR report key: 22811989 · Received August 14, 2025

    Report

    Report Number
    1911916-2025-00583
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    March 9, 2025
    Report Date
    August 26, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    00382903065943
    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

    (B)(4). FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306594 AND LOT NUMBER 4211514. 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.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: ON (B)(6) 2025, WHILE SEALING THE IV LINE FOR A PATIENT AFTER INFUSION, IT WAS DISCOVERED THAT THE NEEDLE WAS LEAKING. THE NEEDLE STOPPER WAS OF POOR QUALITY, WITH EXCESS PLASTIC, MAKING IT IMPOSSIBLE TO PUSH THE SOLUTION THROUGH AND SEAL THE LINE IN A TIMELY MANNER. AFTER REPLACING THE PRE-FILLED NEEDLE, THE LINE WAS PROMPTLY SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686889 SYRINGE 5ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 4211514 00382903065943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown