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

Model Number 8-1255-ISOSAF

Device Problems Crack (1135); Fluid/Blood Leak (1250); Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

This report is a response to medwatch report # (b)(4) which was received by amt from the fda on 09/07/2021.Based on the provided information, the complaint 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 has made several contact requests to the reporter to obtain additional information and the device for examination, but we have received no response from the original reporter at this time.The device has not been returned, therefore a visual and functional evaluation could not be performed at the time of this report.A device history review was performed for the lot number provided, with no anomalies found and no similar complaints reported from the same batch.The exact cause for the reported cracking/leakage is unknown at this time.Based on the provided information and the device history review completed, the reported issue is not believed to have been caused by a manufacturing defect.We will provide additional information to the fda if the device(s) or additional information is able to be obtained and any analysis changes the conclusion of this report.

Event Description

Per the original reporter's described event or problem from report #: (b)(4), the following was reported: "problem 1: 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.Problem 2: the outside white ports crack often requiring tubing changes.What was the original intended procedure?: provide tubing for continuous enteral feeding.".

• Brand Name: AMT MINI ONE ENTERAL EXTENSION SET (ENFIT)
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 12586452
• MDR Text Key: 276603362
• Report Number: 1526012-2021-00018
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 00842071116095
• UDI-Public: (01)00842071116095(17)240601(10)210603-440
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8-1255-ISOSAF
• Device Catalogue Number: 8-1255-ISOSAF
• Device Lot Number: 210603-440
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR