MAUDE Adverse Event Report: HALYARD HEALTH, INC. TRANSGASTRIC JEJUNAL, 16F; ENTERAL FEEDING TUBE

Model Number 0650-16

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Halyard health received a report from the (b)(6) stating a hole was noted in the enteral feeding tube and the tube leaked.The device was in use for six months prior to failure.No additional information was provided in regards to the patient's status.Additional information has been requested but not yet received.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and 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 documented in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: TRANSGASTRIC JEJUNAL, 16F
• 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 industial no.40
• Manufacturer Contact: lisa clark ; 5405 windward pkwy.; alpharetta, GA 30004
• MDR Report Key: 4376990
• MDR Text Key: 5238927
• Report Number: 9611594-2014-00196
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K0820253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2015
• Device Model Number: 0650-16
• Device Catalogue Number: 991095834
• Device Lot Number: AA3133N12
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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