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	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that after using for a few minutes, the tube started to leak.No patient harm was reported.
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 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: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 7087397
• Report Number: 1282497-2017-05519
• Device Sequence Number: 19249808
• 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): 03/08/2018

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 Model Number: 8884773006
• Device Catalogue Number: 8884773006
• Device Lot Number: 161690222
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1