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

Model Number 8884720858E

Device Problems Crack (1135); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reports that the feeding tube was stuck in the nasogastric tube and was difficult to remove.When the tube was freed, there was a crack at the y- site of the tube.There was no harm to the patient.

Event Description

Per additional information received, the customer stated the connector from the feeding tube was tightly stuck in the y port connection and the y port cracked, when the health care provider tried to remove it.

Manufacturer Narrative

Event problem and evaluation codes: code updated per additional information received.Event: description updated per additional information received from the customer.There was no crack in the tube, the y port cracked from the force used to free the connection.After receiving additional information clarifying the complaint details it was determined that this report was submitted in error as the incident does not meet the mdr regulation requirements of a reportable event.

• Brand Name: ENTRFLX 8FR;43INW/STYLTY SITE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8896345
• MDR Text Key: 154411376
• Report Number: 9612030-2019-02242
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: 10884521582972
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 1800890164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2019
• Patient Sequence Number: 1