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

Model Number	8884773006
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the reporter, the pump set was leaking from the bottom of the bag.
Additional Manufacturer Narrative
A device history record was reviewed and was confirmed that products were produced accomplishing quality requirements.Two used samples were received for evaluation.The bags were filled with water and immediately leakage were the tubing is sealed with the bag was observed.The failure observed looks like damage on the rings of the seal of the tube.The most probable root cause is related to the sealing machine between the bag and the tubing or incorrect handling at the time of removing from the machine.The root cause of the observed condition was determined to be a result of a manufacturing activity and a process enhancement has been initiated to prevent this condition from recurring.The involved personnel will be notified and the die will be reviewed to assure that it is working as it should.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; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 6898997
• Report Number: 1282497-2017-05375
• Device Sequence Number: 10975646
• Product Code: KNT
• UDI-Device Identifier: 10884521028388
• UDI-Public: 10884521028388
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 01/04/2018

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: 08/31/2021
• Device Model Number: 8884773006
• Device Catalogue Number: 8884773006
• Device Lot Number: 161130180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1