MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 12 FR, 1.5 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0120-12-1.5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 30046412, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided and confirmed the reported incident.A root cause was not identified.All information reasonably known as of 21-jul-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported, "the g-tube broke apart at the level of the booster & stem-the balloon deflated and the distal portion migrated into the stomach, a trip to the ed [emergency department], determined the tube would be allowed to pass naturally [through] the gi tract.A new tube was replaced in the ed." since that time, the patient had multiple "poops" and it is believed the broken end piece was passed in the patient's feces.

• Brand Name: MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 12 FR, 1.5 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10307557
• Report Number: 9611594-2020-00133
• Device Sequence Number: 3217762
• Product Code: KNT
• UDI-Device Identifier: 00350770427003
• UDI-Public: 00350770427003
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: 0120-12-1.5
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 30046412
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1
• Patient Age: 5 YR