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

Lot Number 1243110120

Device Problems Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2022

Event Type  malfunction  

Event Description

Product problem is that the device cracked and split at the y-site junction, requiring the feeding tube to be removed and replaced.Vendor was informed and indicated this is a "known issue" with overtightening of the hub.Partly this is user error, but also the device's integrity ought not depend on how tight the user can twist it to secure it.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: 13315246
• MDR Text Key: 284325007
• Report Number: MW5106858
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1243110120
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic