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

Model Number	716200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scar Tissue (2060); No Code Available (3191)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information regarding the event and initial reporter was requested.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the nutriport was inserted on (b)(6) 2018 and removed (b)(6) 2018.When the second device was removed, the patient did not inform his parents.This caused the stoma to close up as a result of the withdrawal of the device.
Additional Manufacturer Narrative
The device history record file was reviewed indicating that product was released meeting all quality standard requirements.A sample was received.Visual and functional inspection was performed and a pinhole was found on the tip of the balloon.The reported issue was confirmed.A root cause could not be determined.As a result the cure time for the glue was increased and burst testing was initiated and incoming and final inspection.The investigation will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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. 1113 cuidad; tijuana,na 22444 ; MX 22444
• MDR Report Key: 7739587
• Report Number: 9612030-2018-00138
• Device Sequence Number: 11042301
• Product Code: KNT
• UDI-Device Identifier: 10884521011007
• UDI-Public: 10884521011007
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: 716200
• Device Catalogue Number: 716200
• Device Lot Number: 332983164X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/05/2018; 08/08/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/24/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other