MAUDE Adverse Event Report: COVIDIEN ENTRIFLEX FEEDING TUBE

Model Number 8884720825

Device Problems Break (1069); Complete Blockage (1094); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with a feeding tube.The customer states the nurse inserted the tube, and when trying to remove the stylet, it absolutely would not come out.The plastic cap used to pull the stylet actually popped off because the nurse was trying so hard to pull the stylet out.They had to grab the wire with hemostats to pull the wire out.There was no harm to the patient.The next morning they were trying to flush the tube because it was clogged.It was clogged because in the process of pulling the wire/stylet out, it left flat spots throughout the tube.They had to remove this tube and place another weighted tube without a stylet.Additional information has been requested with no response.If additional pertinent information becomes available, the report will be updated.

Manufacturer Narrative

Per additional information received on 12/06/2016, the customers were not activating the hydromer coating.The sales rep educated the customer and left literature regarding that aspect.Not enough water was being used, or none at all.The lot number and sample are not available because they were discarded.

Manufacturer Narrative

Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTRIFLEX FEEDING TUBE
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6139858
• MDR Text Key: 61564867
• Report Number: 9612030-2016-00757
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884720825
• Device Catalogue Number: 8884720825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1