BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANOS

    MDR report key: 18386175 · Received December 22, 2023

    Report

    Report Number
    18386175
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    October 18, 2023
    Report Date
    November 22, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ADMITTED TO NICU (B)(6) 2023 FOR EXTREME PREMATURITY- 5 FR OGT PLACED ON ADMISSION. PATIENT BEGAN TRICKLE FEEDS WITH 5 FR OGT ON (B)(6) 2023 WITH DONOR HUMAN MILK OR EXPRESSED HUMAN MIIK. ON (B)(6) 2023 PATIENT WITH DECREASED BLOOD PRESSURE, DECREASED URINE OUTPUT, PERSISTENT ACIDOSIS, HYPERGLYCEMIA. SEPTIC WORKUP COMPLETED, ANTIBIOTICS INITIATED, ABDOMINAL XRAY REVEALED DECREASED BOWEL GAS WITH NO PNEUMATOSIS OR FREE AIR. PATIENT MADE NPO AND SALEM SUMP TO LCS PLACED. FROM (B)(6) 2023 THROUGH (B)(6) 2023 PT CONTINUED TO DETERIORATE REQUIRING MULTIPLE TRANSFUSIONS, DRIPS FOR BLOOD PRESSURE SUPPORT AND INCREASING VENT SUPPORT. PATIENT DEEMED TO UNSTABLE FOR SURGICAL PROCEDURE PER SURGERY. ON (B)(6) 2023 WITH XRAY SHOWING LARGE AMOUNT OF FREE AIR. PATIENT WITH SURGICALLY PLACED PENROSE DRAIN ON (B)(6). PATIENT SHOWED SIGNS OF IMPROVEMENT AFTER DRAIN PLACED. (B)(6) 2023 PATIENT WITH OPEN EXPLORATORY LAPAROTOMY AND CREATION OF ILEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308206 AVANOS NEOMED FEEDING TUBE WITH ENFIT CONNECTOR BSS AVANOS MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DA Female Life Threatening| R