BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE, LUER LOCK, STERILE, 10ML

    MDR report key: 19001397 · Received March 28, 2024

    Report

    Report Number
    1417592-2024-00236
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    May 13, 2019
    Report Date
    March 28, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FMF
    UDI-DI
    40080196310198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SYRINGE PLUNGER IS "NOT ATTACHED PROPERLY" AND RESULTED IN AIR LEAKAGE INTO THE BARREL. ACCORDING TO THE REPORTING FACILITY, THE PROBLEM/ISSUE IS "ALLOWING AIR TO CONTAMINATE BLOOD SAMPLES CAUSING THEM TO CLOT." NO SERIOUS INJURY, DIAGNOSTIC IMPACT, BLOOD RE-DRAW, OR ADVERSE IMPACT TO A PATIENT OR A 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. THE REPORTED PROBLEM/ISSUE WAS UNABLE TO BE CONFIRMED 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 Manufacturer Narrative · 0

    ADDITIONAL PRODUCT LOT REPORTED = 180621.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE PLUNGER IS "NOT ATTACHED PROPERLY" AND RESULTED IN AIR LEAKAGE INTO THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE PLUNGER IS "NOT ATTACHED PROPERLY" AND RESULTED IN AIR LEAKAGE INTO THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593695 SYRINGE, LUER LOCK, STERILE, 10ML FMF MEDLINE INDUSTRIES, LP SYR110010 180611 40080196310198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other