MAUDE Adverse Event Report: COVIDIEN ENTRFLX 10FR;43IN W/STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721088
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
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.
Event or Problem Description
The customer reported that a feeding tube was inserted in patient and when the placement was confirmed, the guidewire would not come out.The customer further added that more than 10cc of water was flushed inside the ng tube to activate the hydromer coating prior to placement.
Additional Manufacturer Narrative
Evaluation summary a review of the device history record could not be conducted because a lot number was not provided.A sample without original package or lot number was received for evaluation.After performing a visual inspection per procedure, the sample was evaluated.10ml of water was inserted into the tube to activate the hydromer coating.After the water activated the hydromer coating the stylet was able to be removed from the tube.The reported condition was not confirmed.The root cause could not be determined because the stylet was able to be removed.It is possible that the tube was not filled with enough water to remove the stylet smoothly.The instructions for use state, a syringe should be used to inject approximately 10 cc of water into the tube to activate the hydromer coating.Once the tube position has been confirmed, reactivate the hydromer coating with another 10 cc of water before attempting removal if the stylet has been indwelling for any appreciable time.No corrective or preventative action (capa) is deemed necessary at this time.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: ENTRFLX 10FR;43IN W/STY YPORT
• 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: 9355509
• Report Number: 9612030-2019-02364
• Device Sequence Number: 18966373
• Product Code: KNT
• UDI-Device Identifier: 10884521518872
• UDI-Public: 10884521518872
• 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,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: 8884721088
• Device Catalogue Number: 8884721088
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1