MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-20 LAPAROSCOPIC INTRODUCER KIT; DIGESTHEALTH ENTERAL FEED PERC PLACEMENT

Model Number	10226
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as a lot number was not provided.Root cause cannot 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.(b)(4).
Event or Problem Description
It was reported that a patient had a procedure to place a mic-key feeding tube.On (b)(6) 2016 the patient picked at the scab wound and alleged that a small piece of metal came from the scab area.Additional information was received on 20-dec-2016 from the halyard representative who was present during the patient's procedure on (b)(6) 2016.The halyard representative states the procedure was done laparoscopy and the t-fasteners were placed correctly, and the t-fasteners were not tight.The physician completed the procedure with the correct technique.The were no issues or concerns with the procedure that lasted approximately ten minutes.No additional information was provided.
Additional Manufacturer Narrative
Additional information, 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 comp-(b)(4).
Event or Problem Description
Additional information received on (b)(6) 2017 that states, a patient got an x-ray last week found some other metals and the patient will have another procedure to remove the metals.No additional information provided at this time.

• Common Device Name: DIGESTHEALTH ENTERAL FEED PERC PLACEMENT
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6218374
• Report Number: 9611594-2016-00185
• Device Sequence Number: 575478
• Product Code: KCG
• UDI-Device Identifier: 10680651102260
• UDI-Public: 10680651102260
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2017

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: 10226
• Device Catalogue Number: 991010226
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 02/07/2017
• Patient Sequence Number: 1
• Patient Age: 68 YR