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

Model Number 8884720858E

Device Problem Material Twisted/Bent (2981)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 12/21/2018

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.

Event Description

The customer reports that the nasogastric tube kinks; the ng tube was removed from the digestive tract and noted that the tube had a bend/kink in the digestive tract.A new tube had to be inserted again causing discomfort to the patient.

Manufacturer Narrative

A lot number was not provided, as a result the device history record review could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Initially a photo was provided for a visual evaluation.The photo provided was of a representative sample, not the actual device involved in the incident.A visual evaluation of the photo initially confirmed that the representative sample was broken at the y-port.Using the photo provided we were not able to determine where the breakage generated, as a result we were not able to determine the root cause.The process was reviewed, and it was determined that the breakage was not generated at the manufacturing plant.One decontaminated sample was later returned to the plant for a physical evaluation.The sample arrived without original packaging or the lot number.After performing an evaluation, the reported issue of kinked tubing was confirmed.Based on the available information and the results of the investigation, an exact root cause could not be determined at this time.If additional information is received at a later time, this investigation will be updated as needed.The reported issue of a broken y-port could not be confirmed.The y-port was not observed to be broken on the returned sample.A root cause could not be determined as this reported issue was not confirmed.No corrective actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria.We will continue to monitor the process for any adverse trends that require immediate attention.

Manufacturer Narrative

The reported issue was confirmed.A picture was attached for evaluation.However, the root cause is not able to be confirmed from the picture since it could not be determinate where the rupture originates from.A review of the device history record could not be conducted because a lot number was not provided.No corrective actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria will be keep monitoring the process for any adverse trends that require immediate attention.

Manufacturer Narrative

Based on additional information provided by the initial reporter on 03-jul-2019, it has been determined that the customer initially reported two separate incidents as one event in error.The following sections have been updated: b3 - date of event updated from (b)(6) 2018 to (b)(6) 2018; b5 - describe event or problem updated to reflect corrected event description; d4 - lot number updated from unknown to 1805089464 and udi number added.See updated device evaluation and investigation below: the device history record was reviewed and indicated that the product was released accomplishing all quality standards.One sample without the original packaging or lot number was received at the plant for the investigation.A visual evaluation was performed, and the reported condition was confirmed, the tubing was kinked.A definitive root cause could not be determined at this time.The most likely root cause indicates that this issue could occur due to inadequate use of the product if the instructions for use are not followed.No corrective actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria.We will continue to monitor the process for any adverse trends that require immediate attention.

Event Description

The customer reported the feeding tube was installed according to the procedure on (b)(6) 2018 and the feeding was started.The morning of (b)(6) 2018, the tube was blocked and they were not able to unblock it despite several attempts.The tube was removed to install another.When they removed the tube, they found that it was kinked/bent.A new feeding tube was installed.

• 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: 8233278
• MDR Text Key: 132786270
• Report Number: 9612030-2019-02075
• Device Sequence Number: 1
• Product Code: KNT
• 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,Followup,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• 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: 1805089464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1