MAUDE Adverse Event Report: HALYARD HEALTH, INC TJ TUBE, 16FR JAPAN; ENTERAL FEEDING TUBE

Model Number 0650-22J

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 12/04/2014

Event Type  malfunction  

Event Description

Halyard health received a report from (b)(6) stating the transgastric enteral feeding tube burst after one week while in use.No additional information was provided in regards to the patient's status.Additional information has been requested but not yet received.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in progress.Upon completion of the investigation, a follow-up report will be filed.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is document in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: TJ TUBE, 16FR JAPAN
• Type of Device: ENTERAL FEEDING TUBE
• Manufacturer (Section D): HALYARD HEALTH, INC; alpharetta GA
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industial no.40
• Manufacturer Contact: lisa clark ; 5405 windward pkwy; alpharetta, GA 30004
• MDR Report Key: 4412518
• MDR Text Key: 5415285
• Report Number: 9611594-2015-00002
• 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,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2016
• Device Model Number: 0650-22J
• Device Catalogue Number: 991095849
• Device Lot Number: AA4153N32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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