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

Model Number 8884721088E

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 05/14/2020

Event Type  malfunction  

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 Description

The customer reported that the guidewire would not come off of the nasogastric tube after insertion of the tube.It could not be removed.The patient experienced discomfort.A new nasogastric tube must be inserted when the removal of the guide wire is impossible.Before inserting the nasogastric tube, the guidewire must be pulled 10 to 15 cms in order to be able to then remove it after the nasogastric tube has been inserted.

• Brand Name: ENTRFLX 10FR;43IN W/STY YPORT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10384521
• MDR Text Key: 202194758
• Report Number: 9612030-2020-02556
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884721088E
• Device Catalogue Number: 8884721088E
• Device Lot Number: 1733188164
• Date Manufacturer Received: 08/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1