MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884773006
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 2017-09-26.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
According to the reporter, the device had a leakage while using on patient.
Additional Manufacturer Narrative
A device history record was reviewed and was confirmed that products were produced accomplishing quality requirements.Three samples were received for evaluation.A functional inspection was performed; the bag was filled with water and leaking at the seal was immediately observed.Damage was found on the rings of the seal of the tube.A root cause can be due to an issue with the sealing machine between the bag and tubing or incorrect handling when the product is removed from the machine.The manufacturing personnel involved were notified of the reported issue and the sealing machine will be reviewed.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): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 6894534
• Report Number: 1282497-2017-05367
• Device Sequence Number: 13653251
• Product Code: KNT
• UDI-Device Identifier: 10884521028388
• UDI-Public: 10884521028388
• 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): 01/03/2018

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: 08/31/2021
• Device Model Number: 8884773006
• Device Catalogue Number: 8884773006
• Device Lot Number: 161130180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1