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

Model Number	8884720858
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
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 a nurse was inserting a ng tube on a patient and when she went to pull out the stylet, it broke at the hub.The ng tube was removed without injury to the patient.Additional information received on (b)(6) 2020 stated that per the nurse who placed the ng tube, the stylet fully detached from the guide wire.
Additional Manufacturer Narrative
The initial report was submitted with the incorrect device code in section h6 in error.The device code has been corrected from 1250 (fluid leak) to 2907 (detachment of device or device component).
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Physical samples were not received for the investigation.However, two photos were provided.The photos were visually evaluated, and the reported issue was confirmed, the green adapter was detached from the guidewire.A root cause analysis indicated that this issue likely occurred as a result of opportunities for improvement in the assembly method.As part of continuous improvements, the standard work instructions have been updated to include more detailed instructions of the process steps for the operator to follow to ensure adequate assembly of the stylet and the hub, this includes detailed steps to follow in the use of the assembly machine and the proper use of fixture.These actions are designed to prevent the recurrence of the reported issue.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: 10442009
• Report Number: 9612030-2020-02581
• Device Sequence Number: 19511570
• Product Code: KNT
• UDI-Device Identifier: 10884521518858
• UDI-Public: 10884521518858
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2020

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: 2011201364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 08/21/2020; 08/21/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/24/2020; 10/14/2020
• Patient Sequence Number: 1