MAUDE Adverse Event Report: HALYARD HEALTH, INC. TJ TUBE, 22FR JAPAN; ENTERAL FEEDING TUBE

Model Number 0650-22J

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Halyard health received a report from (b)(6) stating the enteral feed nutrition solution could not flow through the tube.The transgastric enteral feeding tube was replaced.No additional info was provided in regards to the pt's status.Additional info has been requested but not yet received.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for eval.A review of the device history record is not possible as no lot number was provided.Upon completion of the sample eval; a follow-up report will be filed.Halyard health has no independent knowledge of the event reported but is relaying the info that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: TJ TUBE, 22FR JAPAN
• Type of Device: ENTERAL FEEDING TUBE
• Manufacturer (Section D): HALYARD HEALTH, INC.; alpharetta GA
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; circuito industrial no. 40; colonia obrera; nogales, sonora ; MX
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004
• MDR Report Key: 4347528
• MDR Text Key: 5176297
• Report Number: 9611594-2014-00181
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0650-22J
• Device Catalogue Number: 991095849
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other