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

Model Number 8-2455-ISOSAF

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

This report is a response to medwatch report # (b)(4) which was received by amt from the fda on 08/26/2019.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.Complaint # (b)(4) was assigned to this report.Analysis of the returned device consisted of a visual and functional evaluation, as well as a device history review.Examination of the device determined that a small tear had occurred through the strap plug of the med-port.This allowed for the port to easily pop open and/or leak when pressurized during use.The exact cause for the tear in the plug is unknown at this time.We have attempted to replicate the tear in the lab using several methods, but have been unsuccessful in replicating the tear visualized in the returned product.Based on the provided information and the evaluation completed it is not believed to have been caused by a manufacturing defect.We will provide additional information to the fda if the device or additional information is able to be obtained and its analysis changes the conclusion of this report.

Event Description

Applied medical technology received voluntary event report #(b)(4) from the fda medwatch program.The report states that there were two cracks on the gt extension; one on the med port and one on the feeding port.

• Brand Name: AMT MINI ONE® ENTERAL EXTENSION SET
• Type of Device: ENTERAL EXTENSION SET
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd.; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC; 8006 katherine blvd; brecksville OH 44141
• Manufacturer Contact: sarah beercheck ; 8006 katherine blvd.; brecksvile, OH 44141 ; 4402622541
• MDR Report Key: 9087973
• MDR Text Key: 188326534
• Report Number: 1526012-2019-00002
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8-2455-ISOSAF
• Device Lot Number: 190604-016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1