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

Model Number	8884710859
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Submit date: 11/15/2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that the feeding tube placement possibly caused an esophageal rupture despite the feeding tube being placed without complication.The patient was admitted to the hospital with a (b)(6) requiring an ngt; her existing ngt was exchanged later in her stay for an entroflex to promote some oral intakes as the patient approached discharge to a rehab hospital.Forty eight hours after the placement of the ngt, the patient developed worsening respiratory status with thoracentesis c/w esophageal rupture (amylase 500).Despite bilateral chest tubes and broadening of antibiotics, the patient's condition status continued to deteriorate as she was a poor surgical candidate (severe aortic stenosis).The patient progressed to comfort measures only.
Additional Manufacturer Narrative
The device history record file was reviewed indicating that product was released meeting all quality standard requirements.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 deemed necessary at this time.The process is running according to product specifications meeting quality acceptance criteria.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): COVIDIEN; calle 9 sur no.125; cuidad industrials; tijuana,na 22444 ; MX 22444
• MDR Report Key: 7032569
• Report Number: 9612030-2017-05237
• Device Sequence Number: 1770038
• Product Code: KNT
• UDI-Device Identifier: 10884521009196
• UDI-Public: 10884521009196
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8884710859
• Device Catalogue Number: 8884710859
• Device Lot Number: 1712287764
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention