MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. ENFIT AMT MINI ONE ENTERAL EXTENSION SET; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Catalog Number 8-1266-ISOSAF

Device Problems Crack (1135); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2021

Event Type  malfunction  

Event Description

The nurses reported that the new enfit amt mini one enteral extension sets leak out the medication port when the tube feedings are infusing.The nurses reported that the cap does not fit securely and when the continuous feedings are infusing the medication port cap pops off.The outside white ports crack often requiring tubing changes.

• Brand Name: ENFIT AMT MINI ONE ENTERAL EXTENSION SET
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 12413224
• MDR Text Key: 269606175
• Report Number: 12413224
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8-1266-ISOSAF
• Device Lot Number: 210603-440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2190 DA