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

Model Number	8884711006E
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Kangaroo¿ feeding tube with dobbhoff tip placed by registered nurse (rn) without difficulty.Kidney, ureter and bladder (kub) x-ray obtained and confirmed placement.Attempted to remove guide wire without success.Kangaroo¿ feeding tube removed per md order and replaced.Second kangaroo¿ feeding tube placed without difficulty however guide wire unable to be removed.Second kangaroo¿ feeding tube removed and md notified.No known patient harm at this time.Packaging states "attention: please activate hydromer coating prior to stylet removal." no instruction on how to "activate hydromer coating" on packaging or on manufacturer website.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 20460770
• Report Number: 20460770
• Device Sequence Number: 12975718
• Product Code: KNT
• UDI-Device Identifier: 10884521582903
• UDI-Public: (01)10884521582903(17)280930(10)2330406664
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/25/2024
• Report Date (Section F): 07/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884711006E
• Device Catalogue Number: 8884711006E
• Device Lot Number: 2330406664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/25/2024