BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAIN FISTULA NEEDLE 15GX1, FIXED

    MDR report key: 17524575 · Received August 12, 2023

    Report

    Report Number
    MW5131521
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    November 24, 2020
    Manufacturer
    BAIN MEDICAL EQUIPMENT (GUANGZHU) NO. I 0, JUNCHEN
    Product Code
    FIE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A USER FACILITY REGISTERED NURSE(RN) REPORTED VIA FAX THAT THERE WAS BLEEDING AROUND THE VENOUS BAIN NEEDLE SITE. (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
    2182424 BAIN FISTULA NEEDLE 15GX1, FIXED NEEDLE, FISTULA FIE BAIN MEDICAL EQUIPMENT (GUANGZHU) NO. I 0, JUNCHEN 9-09SG-0 202002010541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown