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

Model Number	8884773006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 2017-09-27.
Event or Problem Description
According to the reporter, prior to priming, the dropper separated from the feeding tube.
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.Four used samples were received for evaluation.The multidisciplinary team evaluated the samples and the results were that the silicon tube was disassembled between the mystic connector.A functional test was performed and the silicon was assembled with the mystic connector and was working; a detachment was not observed during the test.Therefore, the failure mode could not been duplicated.The last sample was also tested and was found to be working properly.No corrective actions will apply since failure mode has not been confirmed to any manufacturing issue with samples provided.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: 6897677
• Report Number: 1282497-2017-05370
• Device Sequence Number: 810133
• 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): 12/19/2017

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 Model Number: 8884773006
• Device Catalogue Number: 8884773006
• Device Lot Number: 131990004X
• 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: 09/27/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1