MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 14 FR, 0.8 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0120-14-0.8
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient became ill.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 27-mar-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 enteral tube severed during the patient's transfer between chairs, and part of tube was retained inside of the patient¿s gastrointestinal tract.The patient was taken to the hospital and the medical team opted not to operate and remove the severed piece.A new device was placed, patient went home, patient got ill, and food spilled onto the floor.Patient was admitted back into emergency department.The clinicians decided the safest thing to do was to let the remaining part of the device pass through the intestinal tract.

• Brand Name: MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 14 FR, 0.8 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9896808
• Report Number: 9611594-2020-00053
• Device Sequence Number: 2788958
• Product Code: KNT
• UDI-Device Identifier: 00350770948393
• UDI-Public: 00350770948393
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

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 Model Number: 0120-14-0.8
• Device Catalogue Number: 109483902
• 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: 03/02/2020
• Initial Report FDA Received Date: 03/30/2020
• Patient Sequence Number: 1
• Patient Age: 4 YR