MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA KANGAROO; PUMP, INFUSION, ENTERAL

Model Number	674669
Medical Device Problem Codes	Detachment Of Device Component (1104); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 2017-08-03.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter during use the enteral feeding set's tubing disconnected from the adapter causing leakage.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.A root cause could not be determined.A corrective action is not applicable at this time.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: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 6764067
• Report Number: 1282497-2017-05261
• Device Sequence Number: 19038052
• Product Code: LZH
• UDI-Device Identifier: 10884521028258
• UDI-Public: 10884521028258
• 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
• Report Date (Section B): 11/14/2017

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: 07/02/2019
• Device Model Number: 674669
• Device Catalogue Number: 674669
• Device Lot Number: 151840085X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1