MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE WITH SECUR-LOK (CE); DH EF BALLOON TUBES PRODUCTS

Model Number	0120-16-1.2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as a complete lot number was not provided.The actual complaint product was not returned for evaluation.Photos provided by the customer were reviewed and showed the plug comes off of the strap.There are no activities or tools that could cause this type of flaw in the tube component.Root cause could not be determined.All information reasonably known as of 17 jun 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
Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units, involving the same patient.This is the first of four reports.Refer to 9611594-2020-00104 for the second report.Refer to 9611594-2020-00105 for the third report.Refer to 9611594-2020-00106 for the fourth report.It was reported that the port plug portion of the gastric port cover broke off and clogged the tube.The tube was flushed without the realization that the plug portion was inside the tube, and the plug was pushed into the patient's stomach.No patient injury was report.Photos were provided.Additional information has been requested but not yet received.

• Brand Name: MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE WITH SECUR-LOK (CE)
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10175262
• Report Number: 9611594-2020-00103
• Device Sequence Number: 2924482
• Product Code: KNT
• UDI-Device Identifier: 00350770948652
• UDI-Public: 00350770948652
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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: Lay User/Patient
• Device Model Number: 0120-16-1.2
• Device Catalogue Number: 109486502
• Device Lot Number: UNKNOWN
• 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: 05/27/2020
• Initial Report FDA Received Date: 06/19/2020
• Patient Sequence Number: 1