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

Model Number 0650-16

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

(b)(4) received a report from (b)(6) stating the balloon burst after 3 to 4 weeks in use.There was no change in the patient's care, but the liver failure is worsening.Additional information received on (b)(6) 2014 stated the patient was admitted to hospital and the enteral feeding tube was changed in the radiology department.No additional information was provided in regards to the patient's status.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.(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 parkway; alpharetta, GA 30004
• MDR Report Key: 4321064
• MDR Text Key: 5206768
• Report Number: 9611594-2014-00171
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0650-16
• Device Catalogue Number: 991095834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization