MAUDE Adverse Event Report: COVIDIEN ENTRFLX 8FR;36INW/STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720825
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that when she put the tube in, there was a blockage.On (b)(6) 2019 the customer clarified that when the patient's mother placed the tube through the nose, there was a blockage and nothing could pass.Additionally, the customer mentioned that there were no clinical consequences as a result of this complaint, only that nothing went through the tube.
Additional Manufacturer Narrative
The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.Samples without original package or lot number were received for evaluation.After performing a functional inspection per procedure the condition reported was not observed in the sample.The reported condition could not be confirmed.The root cause of the reported condition could not be determined.The process is running according to product specifications meeting quality acceptance criteria.No corrective actions are deemed necessary at this moment.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 8FR;36INW/STYLTY SITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8942094
• Report Number: 9612030-2019-02260
• Device Sequence Number: 3011496
• Product Code: KNT
• UDI-Device Identifier: 10884521518827
• UDI-Public: 10884521518827
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: No Information
• Device Model Number: 8884720825
• Device Catalogue Number: 8884720825
• Device Lot Number: 1727780164
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 12/05/2019
• Patient Sequence Number: 1