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

Model Number	461043E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 2/8/2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that the iris feeding tube was leaking.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.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 not confirmed; the tubing was not found to be leaking.A root cause could not be determined as the reported issue was not confirmed.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANAGROO IRIS
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7250777
• Report Number: 1282497-2018-00090
• Device Sequence Number: 738526
• Product Code: KNT
• UDI-Device Identifier: 10884521706125
• UDI-Public: 10884521706125
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/05/2018

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: Health Professional
• Device Expiration Date: 11/02/2018
• Device Model Number: 461043E
• Device Catalogue Number: 461043E
• Device Lot Number: 1043110216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2018
• Supplement Date Received by Manufacturer: 01/14/2018; 01/14/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 12/05/2018; 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1