BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSAFE PRE-FILLED NORMAL SALINE FLUSH SYRINGE

    MDR report key: 18760149 · Received February 21, 2024

    Report

    Report Number
    MW5151837
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Report Date
    February 20, 2024
    Manufacturer
    AMSINO MEDICAL (KUNSHAN) CO., LTD.
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A REGISTERED NURSE REPORTED TO CUSTOMER SERVICE THAT PLUNGER CAME OUT OF AMSINO INTERNATIONAL INC 10ML 0.9% NACL(SODIUM CHLORIDE) INJECT USP(UNITED STATES PHARMACOPEIA) PFS WHEN PULLING BACK A CVC(CENTRAL VENOUS CATHETER) WITHOUT RESISTANCE; ALSO, VERY DIFFICULT TO REMOVE AIR BUBBLE BEFORE USING THE SYRINGE ON PATIENTS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238634 AMSAFE PRE-FILLED NORMAL SALINE FLUSH SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT AMSINO MEDICAL (KUNSHAN) CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown