MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* GASTRIC-JEJUNAL FEEDING TUBE KIT - 18 FR, 3.5 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-18-3.5-45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No code available (gastro-jejunal tube migrated out of place).The actual complaint product 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.All information reasonably known as of (b)(6) 2018 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 the gastro-jejunal tube migrated out of place.The user reports resolving the issue by repositioning and by placing a 20fr 55cm or that¿s what she was told.The patient knew the 20fr is or was right because it was labeled on the tube.Additional information received (b)(6) 2018 stated the device was placed (b)(6) 2018.The tube migrated out of the patient's mouth and the patient reports pushing the tube back in the mouth.There was no reported injury.No additional information was provided.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7383246
• Report Number: 9611594-2018-00042
• Device Sequence Number: 16406913
• Product Code: KNT
• UDI-Device Identifier: 10680651956689
• UDI-Public: 10680651956689
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Patient
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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: Lay User/Patient
• 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: 03/08/2018
• Initial Report FDA Received Date: 03/29/2018
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 45