MAUDE Adverse Event Report: CARDINAL HEALTH KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 461243E

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

Covidien feeding tubes with iris have always had terrible printing: depth markings (tick marks with numbers every 5cm ) are always too small and somewhat blurry.This particular feeding tube had illegible numbers due to severity of blurring.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 19019633
• MDR Text Key: 339115160
• Report Number: 19019633
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 461243E
• Device Catalogue Number: 461243E
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1