MAUDE Adverse Event Report: COVIDIEN KANGAROO POLYURETHANE FEEDING TUBE 6.5 FR

Model Number	461438
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While assessing the placement of the og tube, the entire purple cap disconnected from the tubing.I removed the og tube from the patient and replaced it with a new tube.

• Brand Name: KANGAROO POLYURETHANE FEEDING TUBE 6.5 FR
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 7337390
• Report Number: MW5075841
• Device Sequence Number: 2312039
• Product Code: KNT
• UDI-Device Identifier: 10884521067950
• UDI-Public: (01)10884521067950(17)230101(10)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: 461438
• Device Catalogue Number: 461438
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 DA
• Patient Weight: 1