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

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event 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 second of three reports.Refer to 9611594-2021-00032 for the first 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.

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.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).

• Brand Name: MIC GASTRIC-JEJUNAL FEEDING TUBE KIT - ENDOSCOPIC/RADIOLOGIC PLACEMENT - 22 FR
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11422898
• MDR Text Key: 280449654
• Report Number: 9611594-2021-00033
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770954875
• UDI-Public: 00350770954875
• Combination Product (y/n): N
• PMA/PMN Number: K921370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1