MAUDE Adverse Event Report: COVIDIEN KANGAROO GASTROSTOMY FEEDING TUBE WITH Y PORTS; NONE

Device Problems Dislodged (1179); Device Dislodged or Dislocated (2923)

Patient Problem Feeding Problem (1850)

Event Date 10/21/2015

Event Type  Injury  

Event Description

A (b)(6) had covidien kangaroo gastrostomy feeding tube with 6 ports placed on (b)(6) 2015.The tube became dislodged and on (b)(6) 2015 the pt was returned to surgery.The feeding tube was removed and a peg tub was placed.Investigation is ongoing at this time.

• Brand Name: KANGAROO GASTROSTOMY FEEDING TUBE WITH Y PORTS
• Type of Device: NONE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 5213382
• MDR Text Key: 30977303
• Report Number: 5213382
• Device Sequence Number: 1
• Product Code: KNT
• 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: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2015
• Distributor Facility Aware Date: 10/21/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2015
• 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): Required Intervention
• Patient Age: 55 YR