MAUDE Adverse Event Report: COVIDIEN ENTRIFLEX FEEDING TUBE

Model Number 8884721252

Device Problems Detachment Of Device Component (1104); Positioning Problem (3009)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

Submit date: 12/23/2015.An investigation is currently under way.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a feeding tube.The customer states that the probe went into the patients right lung.As a result, pneumothorax occurred.This was seen in the chest x-ray.When the guidewire was pulled out, the customer noticed that the weighted tip had fallen apart and the tube fell apart.

Manufacturer Narrative

The device history record file was reviewed indicating that product was released meeting all quality standard requirements.There were no non-conforming issues reported during the manufacture of this product for a similar condition as reported in this complaint.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.Advertent bronchopulmonary displacement and consequently pneumothorax of the nasal or oral enteric feeding tubes is a well-studied and well documented complication of current placement techniques for blindly placing the nasal or oral enteric feeding tubes.As per the instructions for use, it warns that adverse effects like pneumothorax, intestinal perforation and aspirational pneumonia have been reported during the use of this type of device, therefore due to the extreme caution this device should only be inserted by a trained clinician.The process to manufacture the device was running according to the defined parameters and specifications.The products met the corresponding quality acceptance criteria.The production personnel were notified about the reported issue.A corrective action is not required at this time.Covidien will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5323817
• MDR Text Key: 34267732
• Report Number: 9612030-2015-00126
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 411983864X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other