MAUDE Adverse Event Report: HALYARD HEALTH, INC. MIC-KEYLOW-PROFILE TRANSGASTRIC-JEJUNAL FEED; ENTERAL FEEDING TUBE

Model Number 0650-18-30

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

Patient Problem No Information (3190)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

Halyard health received a report from (b)(6) stating the enteral feeding balloon burst.The device was in use for 21 days prior to the failure.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: MIC-KEYLOW-PROFILE TRANSGASTRIC-JEJUNAL FEED
• 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: 4376992
• MDR Text Key: 5119518
• Report Number: 9611594-2014-00195
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,User Facility,Company Representative
• 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: Lay User/Patient
• Device Model Number: 0650-18-30
• Device Catalogue Number: 991095845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2014
• 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