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

Model Number	461438
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported the connection is coming apart from the tube.The purple port on the feed tube detached from the tube itself.
Additional Manufacturer Narrative
The device history record file was reviewed indicating that product was released meeting all quality standard requirements.There were no physical samples submitted; however, a photo of the sample was received.Based on the photo, the reported condition is confirmed.Without a physical sample, a root cause could not be determined.A corrective action is not necessary at this time.This information will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The device history record file was reviewed indicating that product was released meeting all quality standard requirements.There were no physical samples submitted; however, a photo of the sample was received.Based on the photo, the reported condition is confirmed.Without a physical sample, a root cause could not be determined.A corrective action is not necessary at this time.This information will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125; cuidad industrials; tijuana,na 22444 ; MX 22444
• MDR Report Key: 7494947
• Report Number: 9612030-2018-00080
• Device Sequence Number: 10846256
• Product Code: KNT
• UDI-Device Identifier: 20884521067957
• UDI-Public: 20884521067957
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 08/01/2022
• Device Model Number: 461438
• Device Catalogue Number: 461438
• Device Lot Number: 1720620264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1