MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT MINIONE® EXTENSION SET; ENTERAL EXTENSION SET

Model Number E8-1255-ISOSAF

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Event Description

As reported by the original reporter (report #: (b)(4)): amt mini one® right angle extension feeding set leaking on tubing when flushed.The gastronomy extension set was changed.What was the original intended procedure?: gastrostomy tube - feeding of infant patient.

Manufacturer Narrative

This report is a response to report # (b)(4) which was received by amt from the fda on 11/15/2021.Based on the provided information, the incident is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Amt reached out to the reporter in attempts to retrieve the device for examination.The reporter is still checking into whether they have the device.Since the device was not returned, a visual and functional evaluation could not be performed and device failure could not be confirmed.A device history review found no defects and no similar complaints have been reported from the same manufactured batch.Based on the provided information the reported problem is not believed to have been caused by a manufacturing defect.Complaint # (b)(4) was assigned to this report.We will provide additional information to the fda if additional information is able to be obtained and its analysis changes the conclusion of this report.

• Brand Name: AMT MINIONE® EXTENSION SET
• Type of Device: ENTERAL EXTENSION SET
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: lindsay saylor ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 13001952
• MDR Text Key: 283951789
• Report Number: 1526012-2021-00020
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E8-1255-ISOSAF
• Device Catalogue Number: E8-1255-ISOSAF
• Device Lot Number: 210603-449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 9 MO
• Patient Sex: Female