MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 18 FR, 3.5 CM, 45 CM; DIGESTHEALTH ENTERAL FEED TUBE KITS

Model Number	0270-18-3.5-45
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Difficult To Position (1467)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation at the time this report was filed.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 27jun2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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).Device not returned.
Event or Problem Description
It was reported by the caregiver that the patient was taken to the emergency room because the jejunal portion of the transgastric-jejunal (gj) feeding tube, migrated into the esophagus on (b)(6)2017.The caregiver stated, the issue was resolved by the physician replacing the gj tube with a g-tube.The physician stated the gj was originally placed two weeks ago, exact date unknown.The physician was unable to get the tube past the duodenum.The caregiver stated the patient previously had a standard implanted j-tube which worked without issue, but preferred the aesthetic of the low-profile tube.The patient is currently stable and the physician is pursuing various j-tube options.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: 6680659
• Report Number: 9611594-2017-00095
• Device Sequence Number: 16548083
• Product Code: KNT
• UDI-Device Identifier: 10680651956689
• UDI-Public: 10680651956689
• Combination Product (Y/N): N
• 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): 06/12/2017

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: 0270-18-3.5-45
• Device Catalogue Number: 991095668
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 06/30/2017
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 53