MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 2.0 CM, 30 CM; ENTERAL FEEDING TUBE

Model Number 0270-16-2.0-30

Device Problem Split (2537)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record for the lot number, aa5173n29, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One sample device was returned.The original packaging was not returned with the device.The molded head and tube appeared to be discolored with foreign substances in the interior of the device while the balloon appeared to be clean without foreign substances on the exterior and interior of the balloon material.The evaluation began with observing the entire device looking for the 1-2cm split in the tubing that was referenced in the customer complaint intake.The balloon was then inflated with 5cc of water and then manipulated to see if there would be leaks from the balloon bonded joints.There was no leakage observed from the balloon or balloon inflation port.The gastric lumen was filled with water with no obstruction noticed during the procedure.The device was then clamped with a hemostat forceps below the gastric skives to provide pressure and then the jejunal port was infused with water, no leakage was observed from the tube.The water exited the device in the correct skives (holes) in the tubing.Interlumen communication with the adjacent lumen was not present during the evaluation.The functionality of device performed as intended and the referenced complaint condition could not be replicated.(b)(4) 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 (b)(4) complaint database and identified as complaint (b)(4).

Event Description

A report was received from (b)(6) stating a split was noted in the tube just below the balloon, approximately 1-2cm in length.The user reported the tube blocked on first feeding and then the tube split while health care professionals attempted to clear the tube.The device was replaced using a new radiological placement procedure.The patient has been using the enteral feeding tube for at least 6 years.There was no reported change in patient's activity.The enteral feeding balloon volume was checked per hospital protocol.

Manufacturer Narrative

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; 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 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5346996
• MDR Text Key: 35623613
• Report Number: 9611594-2016-00008
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK922667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 0270-16-2.0-30
• Device Catalogue Number: 991095640
• Device Lot Number: AA5173N29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR