BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAIN FISTULA NEEDLE 1 5GX I, FIXED

    MDR report key: 17529814 · Received August 12, 2023

    Report

    Report Number
    MW5136737
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    December 1, 2020
    Manufacturer
    BAIN MEDICAL EQUIPMENT
    Product Code
    FIE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A USER FACILITY NURSE REPORTED VIA FAX THAT THE BLOOD WAS LEAKING FROM VENOUS SITE OF THE BAIN NEEDLE DURING TREATMENT AND PROLONGED BLEEDING AFTER TREATMENT. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783605 BAIN FISTULA NEEDLE 1 5GX I, FIXED NEEDLE, FISTULA FIE BAIN MEDICAL EQUIPMENT 202002010048

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown