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

Model Number	714170
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
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 that the g-tube was inserted on (b)(6) 2017 and when flushing the tube after insertion, formula was leaking from the valve.The patient's mother stated that the leaking continued at home.On (b)(6) 2017 the g-tube fell out and a "pinsize" hole was seen on the bottom of the balloon where it attaches to the shaft and there was a large leak of saline from the balloon.
Additional Manufacturer Narrative
The device history record file was reviewed indicating that product was released meeting all quality standard requirements.A sample was received for evaluation.A pinhole was found on the tip of the balloon near the air duct.The reported issue was confirmed.A formal corrective and preventative action was opened for this reported issue.A failure in the adhesive layer between the balloon and shaft was found.A production notification was performed to all personnel to ensure that they are aware on the condition reported by the customer.As a result of the investigation and root cause, actions were taken by the outside supplier to increase the cure time from 48 hours to 72 hours, reduce operator based variation during adhesive application by improving and controlling the dispensing of the adhesive to the distal bond joint, and measure and control cleanroom humidity and temperature.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. 1113 cuidad; tijuana,na 22444 ; MX 22444
• MDR Report Key: 7108591
• Report Number: 9612030-2017-05256
• Device Sequence Number: 18853400
• Product Code: KNT
• UDI-Device Identifier: 10884521010659
• UDI-Public: 10884521010659
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/05/2018

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: No Information
• Device Expiration Date: 01/01/2022
• Device Model Number: 714170
• Device Catalogue Number: 714170
• Device Lot Number: 701084664X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1