BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMT RIGHT ANGLE EXTENSION 12"

    MDR report key: 11087053 · Received December 28, 2020

    Report

    Report Number
    MW5098551
    Event Type
    Injury
    Date Received
    December 28, 2020
    Date of Event
    December 23, 2020
    Report Date
    December 24, 2020
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PRODUCT: RIGHT ANGLE CONNECTOR WITH BOLUS ADAPTER AMT MINI CLASSIC 12 INCH. MANUFACTURER: APPLIED MEDICAL TECHNOLOGIES. MANUFACTURER # 6-1221. PATIENT'S MOTHER CALLED TO SAY PORT CONNECTOR TO G PORT BROKE AND LODGED ITSELF INSIDE THE ORIFICE. ER VISIT WAS REQUIRED TO REMOVE THE BROKEN PIECE. LOT NUMBER OF ITEM: 200511-168. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549759 AMT RIGHT ANGLE EXTENSION 12" TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC 6-1221 200511-168

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization