MAUDE Adverse Event Report: COVIDIEN KANGAROO DOBBHOFF NASOGASTRIC FEEDING TUBE 8 FR / CH (2.7 MM) X 43" (109 CM) ; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884710859
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An 8 fr dobbhoff placed for feeding and guide wire snapped causing tube to have to be completely removed.Attempted with 2nd 8 fr dobbhoff and guide snapped again while trying to remove and dobbhoff had to be completely removed.Moved forward with placing small bore ng sump tube without difficulty.Fda safety report id# (b)(4).

• Brand Name: KANGAROO DOBBHOFF NASOGASTRIC FEEDING TUBE 8 FR / CH (2.7 MM) X 43" (109 CM)
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9244550
• Report Number: MW5090671
• Device Sequence Number: 11288759
• Product Code: KNT
• UDI-Device Identifier: 10884521518766
• UDI-Public: (01)10884521518766
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/23/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8884710859
• Device Catalogue Number: 8884710859
• Device Lot Number: 1908302664
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 26