BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE, 10ML SALINE IN 10ML

    MDR report key: 18937354 · Received March 19, 2024

    Report

    Report Number
    2027791-2024-00022
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    May 23, 2019
    Report Date
    March 19, 2024
    Manufacturer
    MEDLINE EXCELSIOR
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CAP OF THE SALINE FLUSH SYRINGE WAS DIFFICULT TO REMOVE. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. EVALUATION OF THE REPORTED PROBLEM/ISSUE WAS PERFORMED USING A RETURNED SAMPLE AND RETAINED SAMPLES. TIP CAP TORQUE TESTING WAS PERFORMED ON ALL SAMPLES AND ALL SYRINGES WERE FOUND TO BE WITHIN SPECIFICATION. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. ADDITIONAL PRODUCT LOTS REPORTED = 3133722, 3134168, 3134290, 3134986.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAP OF THE SALINE FLUSH SYRINGE WAS DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486022 SYRINGE, 10ML SALINE IN 10ML NGT MEDLINE EXCELSIOR EMZE010001 3133246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other