BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML SALINE FILL CHINA SP

    MDR report key: 18536849 · Received January 18, 2024

    Report

    Report Number
    1911916-2024-00024
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    December 28, 2023
    Report Date
    February 5, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065937
    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

    PR (B)(4) : INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4).FOLLOW UP . A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306593 AND LOT NUMBER 2153550. 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. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    AFTER TAKING OUT THE PACKAGE AND INSPECTING IT, IT WAS FOUND THAT THERE WAS NO NEEDLE PLUG IN THE UNOPENED PACKAGE AND IT COULD NOT BE USED NORMALLY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED AFTER TAKING OUT THE PACKAGE AND INSPECTING IT, IT WAS FOUND THAT THERE WAS NO NEEDLE PLUG IN THE UNOPENED PACKAGE AND IT COULD NOT BE USED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818993 SYRINGE 3ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 2153550 30382903065937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown