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

Model Number 461055E

Device Problems Break (1069); Disconnection (1171); Leak/Splash (1354); Material Too Rigid or Stiff (1544); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964); Pressure Problem (3012); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2021

Event Type  malfunction  

Event Description

Reporting multiple product concern reports: enterel feeding tube with iris technology 10 french - 55 inches: the tubing has a port that can become disconnected when in use.There is no way to secure the port (it is under a luer lock), thus tube feeding solution can end up not infusing into the patient.Once this port becomes disconnected, the pump will continue to pump formula all over the patient and the floor.Nurses have tried to tape the port shut to keep it from spilling but it does not secure the tubing correctly.When attempting to change the tubing, the tube feed seemed to have hardened around the port.When attempting to unscrew the tubing, the rubber portion of the dobhoff ripped, and the top plastic part came off with the tubing.Was unable to continue tube feeds, and the port was leaky now.Enteral feeding tube with iris technology 10 french 55 inches: one of the port access became broken when too much pressure was exerted from running tube feed.Tube feeding was attached to access labeled "enteral fluids only".End of broken access port taped and tube feed restarted without further issues.10 french 43 inches: one of the two luer lock port broke, causes leaking and issues with ng tube.Other valve not broken but unable to give feedings with other broken port due to loss in pressure.When attaching tube feeding to port you cannot tighten to tight if not it can cause this issue of the port breaking.10 french 55 inches: port for enteral tube feeding broke during tube feed administration.12 french 43 inches: the purple port tore when rn was trying to pull cap off the medication port to administer meds.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12108473
• MDR Text Key: 259676400
• Report Number: 12108473
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 461055E
• Device Catalogue Number: 461055E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1