MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC SAFETY PEG KIT - PULL METHOD; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	7180-20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Death (1802); Obstruction/Occlusion (2422)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 01 may 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the surgeon "had difficulty removing a 7180-20 peg.The patient refused an endoscopy at that time.[the surgeon] cut the tube at skin level leaving the bumper in the patient¿s stomach.The intention was that hopefully the bumper would pass.The bumper created an obstruction and the patient died.".

• Brand Name: MIC SAFETY PEG KIT - PULL METHOD
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8579426
• Report Number: 3006646024-2019-00007
• Device Sequence Number: 11214891
• Product Code: KNT
• UDI-Device Identifier: 10350770409792
• UDI-Public: 10350770409792
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 7180-20
• Device Catalogue Number: 104097900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death