BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXPOWDER

    MDR report key: 17931078 · Received October 13, 2023

    Report

    Report Number
    17931078
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 2, 2023
    Manufacturer
    NEXTBIOMEDICAL CO., LTD.
    Product Code
    QAU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEXPOWDER TO BE USED FOR HEMOSTASIS DURING ESOPHAGOGASTRODUODENOSCOPY (EGD). CATHETER FOR THE POWDER REMOVED FROM PACKAGING AND WAS KNOTTED UP. WHEN THE REGISTERED NURSE (RN) UNKNOTTED CATHETER, THEY NOTICED THERE WERE SOFT SPOTS IN IT, AND IT WAS KINKED IN MULTIPLE AREAS. THIS CATHETER WAS UNUSABLE, AND A NEW KIT HAD TO BE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683113 NEXPOWDER HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU NEXTBIOMEDICAL CO., LTD. NHS03

    Patients

    Seq Age Sex Outcome Treatment
    1 10950 DA Male