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

Model Number	6-1221
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ENTERAL EXTENSION SET
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• MDR Report Key: 11380788
• Report Number: 1526012-2021-00004
• Device Sequence Number: 4369633
• Product Code: KNT
• UDI-Device Identifier: 00842071107062
• UDI-Public: (01)00842071107062(17)230501(10)200511-168
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K142989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1