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

Model Number	8884730741
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	03/17/2017
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
The customer reported that during an elective exchange of the enteral catheter, two attempts were made to pass through; however, the guide wire broke inside the catheter, at the moment of withdrawal.There were three attempts made to pass the enteral catheter, causing a small amount of bleeding in the patient's nostril.
Additional Manufacturer Narrative
There were no samples submitted with this complaint; therefore, the complaint could not be confirmed.The device history record file was reviewed indicating that product was released meeting all quality standard requirements.The process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A decontaminated sample was received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the sample, the defect was confirmed; the tip was found protruding beyond stylet inner wire nylon.A root cause analysis indicated that this was caused by the user.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 industrial; tijuana,mx 22500 ; MX 22500
• MDR Report Key: 6831455
• Report Number: 2936999-2017-05435
• Device Sequence Number: 861888
• Product Code: KNT
• UDI-Device Identifier: 30884521009619
• UDI-Public: 30884521009619
• 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): 10/11/2018

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: 12/31/2020
• Device Model Number: 8884730741
• Device Catalogue Number: 8884730741
• Device Lot Number: 533585164X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 08/09/2017; 08/09/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 12/06/2017; 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1