MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 18 FR, 2.0 CM, 45 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-18-2.0-45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint sample was returned for evaluation.The balloon was filled with 5 cc of water and was observed for leaks.No leakage was detected from the balloon or balloon inflation port.The balloon was manipulated in order to try and identify a leaking area on the device.No leakage was observed.After examining for the leaks in the balloon, the separation at the distal tip of the tubing was examined, it appeared to have multiple tears and part of the tubing was missing as stated in the complaint description a closer look at the returned sample (under magnification (30x) identified a tearing effect that looks jagged on the tubing walls of the lumens.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.(b)(4).
Event or Problem Description
It was reported that an incident occurred while an infant was being changed.A portion of the feeding tube passed through the infant's feces.The proximal portion of the feeding tube remained in the stomach and the part that was severed passed through the infant¿s intestines into their feces.The tube appeared to have been cut.The infant was taken to interventional radiology to replace the tube.The device was originally placed (b)(6) 2016.There were no injuries, and the infant did not exhibit any signs or symptoms of distress prior to the discovery of the tube found in feces.Additional information received 17-jan-2017 stated the feeding tube was one device that was in two pieces.There was the piece that remained in the stomach that appeared to be cut and the portion that was severed that migrated through the intestine.Even though the device was in two pieces, both pieces are from the same device.No additional information provided.
Additional Manufacturer Narrative
The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 28-sep-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6290268
• Report Number: 9611594-2017-00010
• Device Sequence Number: 13843795
• Product Code: KNT
• UDI-Device Identifier: 10680651956603
• UDI-Public: 10680651956603
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: 0270-18-2.0-45
• Device Catalogue Number: 991095660
• Device Lot Number: AA4322N28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 09/28/2018
• Patient Sequence Number: 1