MAUDE Adverse Event Report: COVIDIEN ENTRFLX 8FR;43INW/STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720858
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
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 the probe has not been able to deliver the feeding.Additional information received from the customer stated that before the catheter was used, it was tested with water and a blockage was noticed in the catheter.No patient harm reported.
Additional Manufacturer Narrative
Correction: h3 evaluation summary: the device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.A sample without its original package or lot number was received for evaluation.After performing a visual inspection per procedure, water was introduced to the dual port adapter connector and it was not possible to confirm the reported condition.The condition reported was not observed in the evaluation of the product.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 plant 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;43INW/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: 9253169
• Report Number: 9612030-2019-02334
• Device Sequence Number: 2104382
• Product Code: KNT
• UDI-Device Identifier: 10884521518858
• UDI-Public: 10884521518858
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 03/25/2020

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: 8884720858
• Device Catalogue Number: 8884720858
• Device Lot Number: 1916907764
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 10/24/2019; 10/24/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 01/21/2020; 03/25/2020
• Patient Sequence Number: 1