MAUDE Adverse Event Report: COVIDIEN UNWTD KANG FEED TUBE 12FR; FEEDING TUBE

Model Number 8884711501

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Regurgitation (2259)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a feeding tube.The customer states that after the tube was in use for some days and checked on a daily basis, the tube has regurgitated at the patients mouth.The tip of the tube migrated out of the stomach and remained in the patients mouth.The lateral cap did not close correctly and opened continuously.As a result they had to place a new tube in patient.

Manufacturer Narrative

This complaint was originally filed as a malfunction; however, upon further review of the complaint, it was determined that migration is not a malfunction of the device.By design, ng tubes do not incorporate a retention device.So it is possible for the device to migrate out of the stomach.Clinicians usually note the depth of insertion or use tape to secure the tube to prevent migration.Since the tip is not designed to prevent migration, it is not a malfunction of the device.The complaint has been updated and this has been deemed to not be a reportable event.

• Brand Name: UNWTD KANG FEED TUBE 12FR
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5530352
• MDR Text Key: 41651661
• Report Number: 9612030-2016-00131
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884711501
• Device Catalogue Number: 8884711501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1