MAUDE Adverse Event Report: COVIDIEN KANGAROO NASAL GASTRIC FEEDING TUBE, DOBBHOFF; TUBE, FEEDING

Device Problem Positioning Problem (3009)

Patient Problems Pneumothorax (2012); Low Oxygen Saturation (2477)

Event Date 04/04/2015

Event Type  Death  

Event Description

Patient underwent dobhoff tube placement at the bedside.An x-ray was ordered but never performed to confirm placement of the tube.Within five minutes after the tube placement the patient began to decompensate.The ventilator alarm sounded and the clinical staff attended to the patient immediately.Patient's sats dropped in the 70's.The dobhoff tube was removed and the patient begin to return to her normal baseline.Several minutes later the patient's alarms begin to sound again as she was decompensating.The patient became unresponsive and a code blue was called.Post code readings of the tube placement x-rays were received after the code which revealed a pneumothorax on the left side.

• Brand Name: KANGAROO NASAL GASTRIC FEEDING TUBE, DOBBHOFF
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 4751529
• MDR Text Key: 5826559
• Report Number: 4751529
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR