MAUDE Adverse Event Report: COVIDIEN KANGAROO NASOGASTRIC FEEDING TUBE WEIGHTED TIP, RIGID PORT AND STYLET

Model Number KANGAROO NASOGASTRIC FEEDING TUB

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

Patient Problem Death (1802)

Event Type  Death  

Event Description

We report the adverse events of the use of nasogastric feeding tubes in six patients in the intensive care unit of (b)(6).We started to use this device since 2013.After the use of this feeding tube we had 6 pneumothorax secondary to the pass to the devices to the airway.In 5 episodes the feeding tube was installed by resident nurse, in one case the medical doctor put the device.All patients has a low mental status at the time of installation of nasogastric tube, in 4 cases the patient has a orotraqueal tube.In all events the diagnosis was made after respiratory impairment and pneumothorax image in the chest plaque.All events was treated by chest tube.Three patients survived and 3 died.In all alive patients the complication extended the hospital stay.Before the time of this report we never had have any complication with the use of nasogastric feeding tubes.

• Brand Name: KANGAROO NASOGASTRIC FEEDING TUBE WEIGHTED TIP, RIGID PORT AND STYLET
• Type of Device: NASOGASTRIC FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; MX
• MDR Report Key: 5324579
• MDR Text Key: 34322346
• Report Number: MW5058709
• Device Sequence Number: 1
• Product Code: FPD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: KANGAROO NASOGASTRIC FEEDING TUB
• Device Catalogue Number: 8884721252
• Device Lot Number: 528982064X
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention