MAUDE Adverse Event Report: COVIDIEN LLC COVIDIEN; KANGAROO

Model Number 8884-721252

Device Problem Positioning Problem (3009)

Patient Problem Pneumothorax (2012)

Event Date 12/04/2014

Event Type  Injury  

Event Description

The patient pulled out her kangaroo feeding tube.Two nurses replaced a new feeding tube at the bedside.X-ray to confirm placement showed the tube to be over the right lung and not passing below the diaphragm.The tube was removed and a new feeding tube was placed by the physician.Confirmation x-ray showed the tube to be coiled back on itself in the pyloric channel.There was a small right pneumothorax also noted.A new tube was then placed under fluoroscopy.Confirmation x-ray showed correct placement, with a large right pneumothorax.The patient required a chest tube and intubation related to the pneumothorax.Reference mfr #: 9612030-2015-00007.

• Brand Name: COVIDIEN
• Type of Device: KANGAROO
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 4528190
• MDR Text Key: 17282493
• Report Number: 4528190
• Device Sequence Number: 1
• Product Code: FPD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: 8884-721252
• Device Lot Number: 425388064X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/04/2014
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR