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

Device Problem Malposition of Device (2616)

Patient Problems Blood Loss (2597); Tissue Breakdown (2681)

Event Date 10/22/2019

Event Type  Injury  

Event Description

Pt warfarin with therapeutic inr came into the ed with hgb 6.Ct showed signs of malpositioned g-j tube.Bleeding thought to be from erosions 2/2 to tube misplacement.Pt got 3 units of blood and tube placement was corrected.

• Brand Name: G-J TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 9279616
• MDR Text Key: 165250256
• Report Number: MW5090873
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 50 YR
• Patient Weight: 78