MAUDE Adverse Event Report: COVIDIEN COVIDIEN KANGAROO POLYURETHANNE FEEDING TUBE

Lot Number 703122064X

Device Problems Air Leak (1008); Positioning Problem (3009)

Patient Problems Internal Organ Perforation (1987); Pneumothorax (2012); Rupture (2208)

Event Date 10/02/2017

Event Type  Injury  

Event Description

Nursing placed the covidien, kangaroo polyurethane feeding tube (5fr.51cm) via the nare.Nursing did not meet resistance following insertion.The catheter was found to have been inserted into the lungs and perforated through the lung (post-traumatic inferior pulmonary ruptured bulla) causing an immediate tension pneumothorax and continuous air leak that required intubation, chest tube placement, and chest compression.Dates of use: (b)(6) 2017.Diagnosis or reason for use: need for enteral feedings related to prematurity.Is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: no.

• Brand Name: COVIDIEN KANGAROO POLYURETHANNE FEEDING TUBE
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 6940198
• MDR Text Key: 89249813
• Report Number: MW5072674
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Lot Number: 703122064X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 10 DA
• Patient Weight: 2