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

Model Number	461412
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Submit date: 11/06/2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports that nursing placed the kangaroo polyurethane feeding tube via the nare.The nurse did not meet resistance following insertion.The catheter was found to have been inserted into the lungs and perforated through the lung (post-traumatic inferior pulmonary ruptured bulla) causing an immediate tension pneumothorax and continuous air leak that required intubation, chest tube placement, and chest compression.
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.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: 7003192
• Report Number: 9612030-2017-05228
• Device Sequence Number: 685333
• Product Code: KNT
• UDI-Device Identifier: 20884521067964
• UDI-Public: 20884521067964
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 02/01/2022
• Device Model Number: 461412
• Device Catalogue Number: 461412
• Device Lot Number: 703122064X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 04/04/2018
• 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