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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2018
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 stated that after using a few minutes, the tube started leaking and it was noticed while using on the patient.No patient injury reported.
Additional Manufacturer Narrative
A device history record review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.One used sample was received at the manufacturing site for evaluation.During functional evaluation it was found that the sample was leaking at the connection between cross spike and tubing line.This complaint will be confirmed as manufacturing related.As part of continuous improvements, a corrective action has been opened which includes assembly process changes and retraining of manufacturing personnel.These actions are designed to prevent the reoccurrence of the reported defective 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; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 7527847
• Report Number: 1282497-2018-00380
• Device Sequence Number: 19165917
• Product Code: KNT
• UDI-Device Identifier: 20884521028385
• UDI-Public: 20884521028385
• 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): 05/09/2019

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 Model Number: 8884773006
• Device Catalogue Number: 8884773006
• Device Lot Number: 170310047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1