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

Model Number 471243E

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Septic Shock (2068)

Event Date 05/12/2022

Event Type  Injury  

Event 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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 14416274
• MDR Text Key: 291953561
• Report Number: MW5109738
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 20884521742229
• UDI-Public: (01)20884521742229
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 149 KG
• Patient Ethnicity: Hispanic
• Patient Race: White