MAUDE Adverse Event Report: COVIDIEN ENTFLX 12FR;43IN W/STYL YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721252

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Pneumothorax (2012)

Event Date 04/16/2020

Event Type  Injury  

Event Description

Customer reports: a light probe with a guide wire which leads the probe to create resistance migrated to the lung, generating pneumothorax.

Manufacturer Narrative

Additional information was received from the customer regarding further patient details.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no samples submitted with this complaint therefore the reported condition could not be confirmed.A product analysis was unable to be completed as to date no samples or pictures have been provided however the instructions for use for the device provides a warning stating that ¿the presence of an endotracheal device tends to guide the feeding tube into the trachea.Should the feeding tube and stylet (if stylet is used) enter the tracheobronchial tree during a tube placement, damage to the lung or esophagus could occur.If any resistance is felt during placement, remove the tube and stylet (if stylet is used) and reinsert.Misplacement of tubes into the lungs resulting in pneumothorax has been reported in neurologically impaired patients and those with tracheal tubes in place¿.This device should only be inserted by a trained clinician.The root cause for the reported condition cannot be specifically identified; therefore, corrective actions will be limited to manufacturing awareness this time.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

Event Description

Per additional information received from the customer, they stated that during the chest x-ray they saw that the probe was positioned at the lung.Three hours after they removed the probe, the patient developed pneumothorax.The female patient was 79 years old with dementia and had a hemorrhagic stroke which evolved with delirium, and after passage of the probe developed pneumothorax.The patient was hemodynamically stable and was also hypertensive and diabetic.Further information was received stating that the patient died however the cause of death is unknown.If additional information is received, a follow up report will be submitted with relevant details.

• Brand Name: ENTFLX 12FR;43IN W/STYL YPORT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10194730
• MDR Text Key: 196411791
• Report Number: 9612030-2020-02508
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 1931214864
• Date Manufacturer Received: 06/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR