MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW PROFILE GASTROSTOMY FEEDING TUBE, 18 FR, 1.7 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0120-18-1.7
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One sample device was returned.The original packaging was not returned with the device.Only the head and strap portion of the mickey were received.The tube and inflation port portions were cut off and were not received.Evaluation of the balloon inflation/deflation issue were not possible due to the adulterated condition of the device.The root cause could not be determined.The device history record (dhr) was reviewed for lot number aa5329f07, and the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.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 by the home health nurse that, "the balloon on the tube placed six months ago will not deflate.A paper clip was used without success so an attempt was made to over-inflate to burst balloon to enable removal of the tube.An appointment had been scheduled with the ostomy nurse for the patient." there were no injuries reported.Additional information was received on 02-mar-2017 that states, "the water would not come out of the balloon to remove the device.The gi ostomy nurse cut the device at the abdomen to release the water so the patient could excrete the balloon.The patient did eliminate the balloon.The ostomy nurse said port was clogged." another like tube was replaced on the patient.There were no injuries reported.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6411969
• Report Number: 9611594-2017-00044
• Device Sequence Number: 47490
• Product Code: KNT
• UDI-Device Identifier: 10680651948844
• UDI-Public: 10680651948844
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K993138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/02/2017

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: Nurse
• Device Expiration Date: 11/01/2017
• Device Model Number: 0120-18-1.7
• Device Catalogue Number: 991094884
• Device Lot Number: AA5329F07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/16/2017
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 16