MAUDE Adverse Event Report: COVIDIEN ENTERAL ACCESS; FEEDING TUBE

Model Number UNK ENTERAL ACCESS

Device Problem Positioning Problem (3009)

Patient Problem Pneumothorax (2012)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a feeding tube.The customer states the patient underwent dobhoff tube placement and sustained bilateral pneumothorax.

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.Uf/importer report # (b)(4).

Manufacturer Narrative

Investigation: the customer states that the patient underwent (b)(4) tube placement and sustained bilateral pneumothorax.A review of the device history record could not be conducted because a lot number was not provided.Manufacturing records are routinely reviewed prior to the release of product to ensure process and product compliance.No samples were received by covidien for evaluation.Because samples were not available for evaluation, the issue reported by the customer could not be confirmed.Root cause analysis stated in the hhe initiation decision 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.In the instruction for use (ifu) for the device the warning is clearly provided that an adverse effect likes 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 defective condition.Based on the information a corrective action from production perspective is not deemed necessary at this time.We 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: ENTERAL ACCESS
• 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: 4915554
• MDR Text Key: 6429791
• Report Number: 9612030-2015-00069
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK ENTERAL ACCESS
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• 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