MAUDE Adverse Event Report: CORPAK MEDSYSTEMS, INC. CORFLO ENTERAL FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	42-1365
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Noticeable defect in feeding tube showed up on x-ray.First thought to be kink then appeared to be a fracture.Enteric tube removed, found to be intact, but large weak spot/ballooning noted near distal end.A new feeding tube was subsequently placed.This tube was in an infant.Pictures available upon request.The tube could have ruptured and portion been retained in the stomach, which would have required endoscopy or surgery for retrieval.Avanos has been contacted regarding issue.Have not received results from analysis yet but there has not been any additional product reports issued on this product.
Event or Problem Description
Noticeable defect in feeding tube showed up on x-ray.First thought to be kink then appeared to be a fracture.Enteric tube removed, found to be intact, but large weak spot/ballooning noted near distal end.A new feeding tube was subsequently placed.This tube was in an infant.Pictures available upon request.The tube could have ruptured and portion been retained in the stomach, which would have required endoscopy or surgery for retrieval.Avanos has been contacted regarding issue.Have not received results from analysis yet but there has not been any additional product reports issued on this product.

• Brand Name: CORFLO ENTERAL FEEDING TUBE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CORPAK MEDSYSTEMS, INC.; 1001 asbury drive; buffalo grove IL 60089
• MDR Report Key: 13505575
• Report Number: 13505575
• Device Sequence Number: 13799992
• Product Code: KNT
• UDI-Device Identifier: 10815149020539
• UDI-Public: 10815149020539
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2022
• Report Date (Section F): 02/02/2022

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
• Device Model Number: 42-1365
• Device Catalogue Number: 42-1365
• Device Lot Number: 77296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/02/2022