MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINIONE GT EXTENSION; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Lot Number 190218-278

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Patient's gt extension cracked at med port.This is the 2nd of 3.(b)(4).

• Brand Name: MINIONE GT EXTENSION
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 8855448
• MDR Text Key: 153408171
• Report Number: MW5088647
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2019
• 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: Health Professional
• Device Lot Number: 190218-278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2019
• 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 Age: 7 YR