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

Model Number	8884742019
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 6/16/2017.
Event or Problem Description
The customer reported that post-operatively the g-tube was leaking.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was invalid.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the complaint and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If the sample is received, the complaint will be reopened for investigation.This complaint will be used 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 ; MX
• MDR Report Key: 6646606
• Report Number: 9612030-2017-05109
• Device Sequence Number: 16388545
• Product Code: KNT
• UDI-Device Identifier: 10884521011663
• UDI-Public: 10884521011663
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/15/2018

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: 05/31/2021
• Device Model Number: 8884742019
• Device Catalogue Number: 8884742019
• Device Lot Number: 613182464X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 05/02/2017; 05/02/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 09/07/2017; 04/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1