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 Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
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.
Event or Problem Description
The customer reported that the ng feeding tube was placed in the icu and then needed to be removed from the patient on the floor because it was leaking.
Additional Manufacturer Narrative
A review of the device history record could not be conducted because a lot number was not provided.A product analysis was unable to be completed as to date no samples or pictures have been provided.Leaking can occur during use if the instruction for use for the proper procedure for the insertion and use of the feeding tube, as well as the correct removal of the stylet using a syringe to inject approximately 10 cc of water into the tube to activate the hydromer coating are not adhered to.Based on the information available and the investigation findings, a formal investigation is not deemed necessary at this time.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.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: 9879102
• Report Number: 9612030-2020-02440
• Device Sequence Number: 11501165
• Product Code: KNT
• UDI-Device Identifier: 10884521582941
• UDI-Public: 10884521582941
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 8884720825E
• Device Catalogue Number: 8884720825E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 05/28/2020
• Patient Sequence Number: 1