MAUDE Adverse Event Report: G-TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Flushing Problem (1252)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 03/17/2021

Event Type  Injury  

Event Description

Nausea; (b)(6) male who arrived by home presented to the emergency department for a tube problem with associated 7/10 severity abdominal pain, onset today pt had a g-tube placed one week ago friday, (b)(6) 2021, and states that he is now having problems with it.Pt is currently taking everything in through the tube including food, water, and medicine.Today, pt states that the tube was working and flushing fine, until a certain point, and now, won't flush at all.He adds that he has vomited three times today as a result and states that the tube is full.Pt reports having normal bowel movements and denies any problems or burning urinating, passing gas, cough, cold symptoms, fevers, or chills.Pt just finished a course of levaquin antibiotics and is taking reglan and zofran all through the tube.Https://ctepcore.Nc1.Mh.Gov/ctepaers/publlc/reportsecuntv?aet1d=676002012.Ticket# (b)(4).

• Brand Name: G-TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 11619009
• MDR Text Key: 244248476
• Report Number: MW5100572
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 87