BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE, LUER LOCK, STERILE, 20ML

    MDR report key: 19009706 · Received April 1, 2024

    Report

    Report Number
    1417592-2024-00321
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    February 28, 2019
    Report Date
    March 31, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FMF
    UDI-DI
    30080196310221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SYRINGE WAS "BACK DRAWING BLOOD BY ITSELF." NO SERIOUS INJURY 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. TWO (2) BOXES OF PRODUCT IN NEW CONDITION WERE RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS UNABLE TO REPRODUCE OR CONFIRM HE REPORTED PROBLEM/ISSUE. 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 = 180615.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE WAS "BACK DRAWING BLOOD BY ITSELF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517167 SYRINGE, LUER LOCK, STERILE, 20ML FMF MEDLINE INDUSTRIES, LP SYR120010Z 180430 30080196310221

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other