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

Model Number 6-1221

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

This report is a response to report # mw5098551 which was received by amt from the fda on 01/28/2021.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 indicated that the device was not saved and could not be returned for examination.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.

Event Description

Per the original medwatch report received with reference #: mw5098551: "patient's mother called to say port connector to g port broke and lodged itself inside the orifice.Er visit was required to remove the broken piece.".

• Brand Name: AMT MINI
• 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: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 11380788
• MDR Text Key: 235009516
• Report Number: 1526012-2021-00004
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00842071107062
• UDI-Public: (01)00842071107062(17)230501(10)200511-168
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2023
• Device Model Number: 6-1221
• Device Catalogue Number: 6-1221
• Device Lot Number: 200511-168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• 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