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 Type  malfunction  

Manufacturer Narrative

This report is a response to medwatch report # mw5088647 which was received by amt from the fda on 08/20/2019.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.The device was not returned therefore a visual and functional evaluation could not be done however, a device history review was performed as the lot number was provided.The exact cause for the crack in the port is unknown at this time.Based on the provided information and the device history review 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 #mw5088647 from the fda medwatch program.The report states that the patient's g-tube extension cracked at the med port and that this was the second of three occurrences.

• 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: 9087980
• MDR Text Key: 207933788
• Report Number: 1526012-2019-00004
• 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: 190218-278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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