MAUDE Adverse Event Report: COVIDIEN KANGAROO FEEDING TUBE WITH IRIS TECHNOLOGY; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	471243E
Health Effect - Clinical Codes	Erosion (1750); Septic Shock (2068)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Covidien kangaroo feeding tube with iris technology eroded through patient stomach and transverse colon causing septic shock and need for emergent surgery.Fda safety report id# (b)(4).

• Brand Name: KANGAROO FEEDING TUBE WITH IRIS TECHNOLOGY
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 14416274
• Report Number: MW5109738
• Device Sequence Number: 4436049
• Product Code: KNT
• UDI-Device Identifier: 20884521742229
• UDI-Public: (01)20884521742229
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2025
• Device Model Number: 471243E
• Device Catalogue Number: 461243E
• Device Lot Number: 1243090120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2022
• 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: Life Threatening
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 149 KG
• Patient Ethnicity: Hispanic
• Patient Race: White