MAUDE Adverse Event Report: HALYARD HEALTH MIC GASTRO-ENTERIC FEEDING TUBES - 20 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	0210-20
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	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 03-apr-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).
Event or Problem Description
It was reported that a patient ended up in the emergency room due to a tube that came our of her mouth, which she pushed back down into her stomach.There was no patient injury.Additional information received on 13-mar-2018 stated that the doctor she works with recommended that the solution to her problem with the tubes coming out of her mouth is to have a jejunostomy tube placed and no longer use a gastrostomy-jejunostomy tube.No further information was received.

• Brand Name: MIC GASTRO-ENTERIC FEEDING TUBES - 20 FR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7397194
• Report Number: 9611594-2018-00049
• Device Sequence Number: 1233123
• Product Code: KNT
• UDI-Device Identifier: 10680651949933
• UDI-Public: 10680651949933
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K852707
• 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): 03/13/2018

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: 0210-20
• Device Catalogue Number: 991094993
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/04/2018
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 45