MAUDE Adverse Event Report: HALYARD HEALTH, INC. MIC* TJ FEEDING TUBE KIT 16 FR, 45CM (ENDO/RADIOL); ENTERAL FEEDING TUBE

Model Number 0250-16

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2015

Event Type  malfunction  

Event Description

A report was received from (b)(6) stating the transgastric enteral feeding tube balloon burst.The device was in use for 27-days prior to the event.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).Method: actual device not evaluated.Results: no results available since no evaluation performed.Conclusions: device not returned.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.(b)(6) 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 comp-(b)(4).Device not returned by customer.

Manufacturer Narrative

According to the documented records for lot number aa4174n12, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.At the time of the device history record review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.Root cause could not be determined.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).

• Type of Device: ENTERAL FEEDING TUBE
• Manufacturer (Section D): HALYARD HEALTH, INC.; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; circuito industrial no 40; colonia obrera; nogales 8404 8; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 4638120
• MDR Text Key: 21176790
• Report Number: 9611594-2015-00044
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/24/2016
• Device Model Number: 0250-16
• Device Catalogue Number: 991095480
• Device Lot Number: AA4174N12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1