MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTRIC-JEJUNAL FEEDING TUBE KIT - ENDOSCOPIC/RADIOLOGIC PLACEMENT - 22 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	0250-22
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 04-mar-2021 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 avanos medical, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical, inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the first of three reports.Refer to 9611594-2021-00033 for the second event.Refer to 9611594-2021-00034 for the third event.It was reported the tubes fractured down where the g-tube and j-tube connect.The patient called and said when they went to irrigate the j-port, there was return via the g port.When it was replaced in the irl, it was noted that the "side wall was blown out on the tube in the distal portion (in stomach)".There was no reported injury.

• Brand Name: MIC GASTRIC-JEJUNAL FEEDING TUBE KIT - ENDOSCOPIC/RADIOLOGIC PLACEMENT - 22 FR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11422858
• Report Number: 9611594-2021-00032
• Device Sequence Number: 17157122
• Product Code: KNT
• UDI-Device Identifier: 00350770954875
• UDI-Public: 00350770954875
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K921370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: 0250-22
• Device Catalogue Number: N/A
• 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: 02/11/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1