BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE,FEEDING,FLT TP W/RNG,IV BAG

    MDR report key: 18909071 · Received March 14, 2024

    Report

    Report Number
    1417592-2024-00328
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    July 30, 2019
    Report Date
    March 14, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    KYZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE FEEDING SYRINGE DID NOT STAY CONNECTED TO A FEEDING TUBE "WITHOUT ANY EFFORT" AND DETACHED. 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 PROBLEMS/ISSUES. NO SAMPLE WAS RETURNED FOR EVALUATION. THE REPORTED PROBLEM/ISSUE WAS IDENTIFIED TO BE A USER PREFERENCE AS NO CLAIM IS MADE THAT FEEDING SYRINGES WILL STAY ATTACHED TO WITH NO EFFORT. 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 LOT REPORTED = 190416.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FEEDING SYRINGE DID NOT STAY CONNECTED TO A FEEDING TUBE "WITHOUT ANY EFFORT" AND DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192513 SYRINGE,FEEDING,FLT TP W/RNG,IV BAG KYZ MEDLINE INDUSTRIES, LP DYND70642 17519030004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other