MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 18 FR, 2.5 CM, 45 CM; DIGESTHEALTH ENTERAL FEED TUBE KITS

Model Number	0270-18-2.5-45
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.
Event or Problem Description
Halyard received a single report that referenced three different incidences, which were associated with separate units involving one patient.This is the first of three reports.Refer to 9611594-2017-00041 for the second report.Refer to 9611594-2017-00042 for the third report.It was reported by the caregiver that; the patient was taken to the hospital three times due to the jejunal portion of the transgastric-jejunal mic key feeding tube migrating back into the stomach.The caregiver stated, the tube was replaced on (b)(6) 2017.The caregiver stated in each instance a fluoroscopy was performed and the same size tube was placed.The caregiver stated the patient experienced emesis regularly and had a "flare up" the previous week and was in the hospital to address the issue.The patient was sent home once the medical "flare up" was managed, but is currently experiencing issues with the tube.The patient receives nutrition through the jejunal portion of the tube and has lost 10-12 pounds recently.The caregiver stated the patient is currently taking miralax daily, with no changes in the formula.The balloon is filled with 8 ml of sterile water.No additional information was provided.

• Common Device Name: DIGESTHEALTH ENTERAL FEED TUBE KITS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6449047
• Report Number: 9611594-2017-00040
• Device Sequence Number: 780892
• Product Code: KNT
• UDI-Device Identifier: 10680651956641
• UDI-Public: 10680651956641
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 03/03/2017

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: Physician
• Device Model Number: 0270-18-2.5-45
• Device Catalogue Number: 991095664
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2017
• Initial Report FDA Received Date: 03/31/2017
• Patient Sequence Number: 1
• Patient Weight: 59