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

Model Number	8884720858
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that there have been multiple concerns brought up by staff when inserting the feeding tubes.The tube frequently curls in the esophagus or stomach during insertion.The guidewire can be challenging to remove after insertion is confirmed for placement, despite having saline instilled.Tubes have sometimes had to be removed after insertion due to the guidewire not coming out.The green cap has also disconnected from the guidewire which required the use of clamps to remove the guidewire.This issue seems to be specific to the individual user.There has been no patient injury or medical intervention associated with any of these events.No other specific details are available at this time.

• 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: 9771297
• Report Number: 9612030-2020-02424
• Device Sequence Number: 19454915
• Product Code: KNT
• UDI-Device Identifier: 10884521518858
• UDI-Public: 10884521518858
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 8884720858
• Device Catalogue Number: 8884720858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/28/2020
• Patient Sequence Number: 1