MAUDE Adverse Event Report: COVIDIEN ENTRIFLEX FEEDING TUBES

Model Number 8884721088

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Internal Organ Perforation (1987); Pneumothorax (2012)

Event Date 01/25/2014

Event Type  Other  

Manufacturer Narrative

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

Event Description

It was reported to covidien on (b)(4) 2014, that a customer had an issue with a feeding tube.The customer reports that there was an incident of a patient with the dh tube inserted through the lung.The nurses reported they followed all directions, soaking it in water prior to insertion.The customer also stated that there was no more resistance met than usual when inserting the tube.The customer reports the date was (b)(6) 2014, the patient was a (b)(6) female, motor vehicle accident.The patient was conscious, just off the ventilator that day.The placement was through the right nare, with no difficulty, and tolerated well.The incident resulted in a small pneumothorax and through the diaphragm.The patient did not need a chest tube placement.A repeat chest x-ray showed improvement.The patient was discharged in stable condition on (b)(6) 2014.No formula was fed into the lungs, as a post-placement x-ray is required prior to use for all dobb-hoff tubes.

• Brand Name: ENTRIFLEX FEEDING TUBES
• Type of Device: FEEDING TUBES
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125; tijuana 92173 ; MX 92173
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125; cuidad industrial; tijuana 9217 3; MX 92173
• Manufacturer Contact: elaine bishop ; 15 hampshire st.; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 4017599
• MDR Text Key: 16588811
• Report Number: 9612030-2014-00045
• 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: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8884721088
• Device Catalogue Number: 8884721088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 08/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other