MAUDE Adverse Event Report: COVIDIEN ENTRIFLEX FEEING TUBES; ENTERAL FEEDING TUBE

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); Lethargy (2560)

Event Date 07/12/2014

Event Type  Other  

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.On (b)(6) 2014, the patient was a (b)(6) female with an altered mental status for 5-6 days at home, possible seizure from benzodiazepine and narcotic withdrawal.The patient was conscious but lethargic and did not follow commands.The placement was through the right nare, no difficulty, and per the nurse, some coughing from the patient but nothing alarming.A post placement x-ray showed moderate right pneumothorax requiring placement of a chest tube.The chest tube was removed on (b)(6) 2014 and the patient was discharged home on (b)(6) 2014 in stable condition.No formula was fed into the lungs, as a post-placement x-ray is required prior to use for all dobb-hoff tubes.

Manufacturer Narrative

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

• Brand Name: ENTRIFLEX FEEING TUBES
• Type of Device: ENTERAL FEEDING TUBE
• 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: 4017598
• MDR Text Key: 4877076
• Report Number: 9612030-2014-00046
• 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