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

Model Number	461503
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported the feeding tube is fused together around the middle of the tubing.There was no patient involved.
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 tubing was observed to be collapsed.A root cause could not be determined at this time.As part of continuous improvements, a corrective action has been opened to implement effective solutions to prevent the reoccurrence of the reported condition.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: 7429323
• Report Number: 9612030-2018-00060
• Device Sequence Number: 2053158
• Product Code: KNT
• UDI-Device Identifier: 20884521067971
• UDI-Public: 20884521067971
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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: 09/01/2022
• Device Model Number: 461503
• Device Catalogue Number: 461503
• Device Lot Number: 1725520064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1