BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBD-SYRINGE, 10ML SALINE IN 10ML

    MDR report key: 19003289 · Received March 29, 2024

    Report

    Report Number
    2027791-2024-00058
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    February 28, 2019
    Report Date
    March 29, 2024
    Manufacturer
    MEDLINE EXCELSIOR
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CAP OF THE SALINE FLUSH SYRINGE WAS DIFFICULT TO REMOVE AND THAT ITS PLUNGER WAS HARD TO PUSH. NO SERIOUS INJURY OR ADVERSE IMPACT TO PATIENT OR USER WAS ORIGINALLY REPORTED. 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. NO PHOTO OR SAMPLE WERE PROVIDED FOR EVALUATION AND A ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 LOT REPORTED = 3133597.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAP OF THE SALINE FLUSH SYRINGE WAS DIFFICULT TO REMOVE AND THAT ITS PLUNGER WAS HARD TO PUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584569 DBD-SYRINGE, 10ML SALINE IN 10ML NGT MEDLINE EXCELSIOR 8881579121 3133316

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other