BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VESCO

    MDR report key: 22156505 · Received June 6, 2025

    Report

    Report Number
    3005670221-2025-00010
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 13, 2025
    Report Date
    June 6, 2025
    Manufacturer
    JIANGSU CAINA MEDICAL CO., LTD.
    Product Code
    FMF
    PMA / PMN Number
    K113091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED SAMPLES OF THIS EVENT WAS REQUESTED BUT HASN'T BEEN RECEIVED TILL NOW, NO SAMPLE FOR EVALUATION. THE DHR OF THIS LOT WAS REVIEWED WITHOUT ANY SIMILAR ISSUE, THE RETAINED SAMPLES WERE INSPECTED AND THEY ALL MEET THE SPECIFICATION. THE EVENT CAN'T BE CONFIRMED, THE ROOT CAUSE CAN'T DETECTED CURRENTLY. NO ACTION WILL BE TAKEN CURRENTLY, THIS ISSUE WILL BE MONITORED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF FURTHER INFORMATION RECEIVED.

    Description of Event or Problem · 0

    WE RECEIVED A CASE OF VESCO 2OML LUER LOCK SYRINGES FROM HEALTH CARE LOGISTICS. CUSTOMER STATED,"TWO TIMES TODAY WE HAVE USED THE SYRINGES, AND THE PLASTIC CRACKED LETTING THE IRON FLUID INSIDE TO SPRAY ACROSS THE TECHNICIAN USING IT. THE LOT NUMBER# 220101. NOT ALL ARE HAVING THIS DEFECT, BUT IT IS A CONCERN AS WEARE A CANCER CENTER AND IF CERTAIN CHEMOTHERAPY MEDICATIONS WERE USED TO DO THIS INSTEAD OF THE IRON IT COULD BE A SEVERE HEALTH HAZARD. VESCO NOW HAS THE DEFECTED SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392402 VESCO DISPOSABLE SYRINGES FMF JIANGSU CAINA MEDICAL CO., LTD. 220101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other