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

Model Number	8884720825E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
Customer reports: the nasogastric tube enfit connection port came loose after a few connections, causing enteral feed to leak from the connection.The tube was replaced due to the ongoing leaking issue.No patient or hcp injury.No additional care was required apart from the product being replaced.
Additional Manufacturer Narrative
A decontaminated sample was received at the plant for the investigation.Because a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Upon a visual evaluation of the sample, the reported issue was confirmed.The analysis performed by the investigation team concluded that the main root cause was due to a workmanship issue generated when an operator fails to apply enough solvent to the enfit connection, deriving in a fragile connection.A new solvent dispenser was implemented for a better solvent application.This new solvent dispenser was implemented in august 2019.However, since the lot number from this incident was not provided, it cannot be confirmed if the reported product was manufactured before or after the actions were implemented.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: 10282583
• Report Number: 9612030-2020-02529
• Device Sequence Number: 19546324
• Product Code: KNT
• UDI-Device Identifier: 10884521582941
• UDI-Public: 10884521582941
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/04/2021

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: 8884720825E
• Device Catalogue Number: 8884720825E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 03/04/2021
• Patient Sequence Number: 1