MAUDE Adverse Event Report: ENTERAL SPECIFIC TRANSITION CONNECTORS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bacterial Infection (1735); Fistula (1862); Necrosis (1971)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

Event involves the enfit enteral feeding connection and enfit feeding tube.It is designed to reduce the number of missed connections.However, the connection does not pull away from the peg tube if tension is detected thus causing the peg to pull against the abdominal wall.This can cause dislodgement and harm to the patient.The patient then requires additional intervention/procedures to correct any potential or actual harm.This patient was found to have a necrotizing soft tissue infection of her abdominal wall and a gastric fistula at the old peg site.Fda safety report id# (b)(4).

• Brand Name: ENTERAL SPECIFIC TRANSITION CONNECTORS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 11444754
• MDR Text Key: 239108729
• Report Number: MW5099861
• Device Sequence Number: 2
• Product Code: KNT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/05/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR