MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 18 FR, 1.5 CM, 30 CM; DEVICE HISTORY ENTERAL FEEDING BALLOON TUBES PRODUCTS

Model Number 0270-18-1.5-30

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

It was reported by the nurse practitioner that a transjejunal enteral feeding tube balloon burst during use.The device was originally placed on (b)(6) 2015.On (b)(6) 2015 a replacement was scheduled to replace the transjejunal enteral feeding tube in the patient.The nurse practitioner will re-evaluate the size chosen for the length of the stoma tube as she was not aware that a 1.2 was available.Additional information was received on (b)(6) 2015 from the nurse practitioner that the tube placement procedure on (b)(6) 2015 was uneventful and the patient is doing well.

Manufacturer Narrative

The sample physical appearance: the molded head, tube and balloon exhibit a slight yellow discoloration.The original packaging was not returned with the device.The balloon was filled with 5 cc's of water and was observed for leaks.No leakage was detected from the balloon or balloon inflation port (bip).The balloon was squeezed and manipulated and there was still no leakage observed.The feed lumen was pressurized from the distal end using a syringe filled with water; no leakage was observed.The sample was filled with 5cc of methylene blue and left on blotter paper overnight and there was no leakage observed.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 documented in the halyard health complaint database and identified as (b)(4).

Manufacturer Narrative

The device history record for the lot number involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.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: DEVICE HISTORY ENTERAL FEEDING BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industial no.40; colonia obrera; nogales 84048 840; MX 84048 8404
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 4770042
• MDR Text Key: 18545394
• Report Number: 9611594-2015-00063
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/22/2016
• Device Model Number: 0270-18-1.5-30
• Device Catalogue Number: 991095653
• Device Lot Number: AA4265N39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 8 YR