MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 14 FR, 1.5 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0120-14-1.5
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 02-jan-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
An fda user facility report #(b)(4) was received, alert date 11 dec 2019.The following information was provided: patient scheduled for percutaneous endoscopic gastrostomy (peg) placement and admitted for observation and use of tube prior to discharge.The tube was never fully functioning (unable to flush a typical volume of medication or formula).Several attempts were made to dislodge tube and/or adjust tube without success.Surgical team was consulted, who also attempted to dislodge/adjust the tube.Patient required surgical intervention to replace tube.Tube was found to be defective with a small membrane the lumen of the tube partially occluding the flow.Patient required three additional days of hospitalization following surgical intervention.Event date: (b)(6) 2019.The deice was in use for one day.Additional information received 17-dec-2019 stated the patient had no residual issues from this incident.
Additional Manufacturer Narrative
The device history record for the reported lot number, aa9203f01, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 24-jan-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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 14 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: 9551032
• Report Number: 9611594-2020-00001
• Device Sequence Number: 10858065
• Product Code: KNT
• UDI-Device Identifier: 10680651948424
• UDI-Public: 10680651948424
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 07/01/2021
• Device Model Number: 0120-14-1.5
• Device Catalogue Number: 109484201
• Device Lot Number: AA9203F01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 MO
• Patient Weight: 7