MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-18 INTRODUCER KIT; DIGESTHEALTH ENTERAL FEED PERC PLACEMENT

Model Number	98433
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint sample was not available for evaluation.It is not possible to determine the root cause of the reported issue without a sample as a proper evaluation could not be performed in order to confirm or duplicate the reported incident.The device history record for the lot number, aa6123r05, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.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
During a maude database review, maude report (b)(4) was identified and stated, the patient was undergoing a gastrostomy tube placement, and while anchoring sutures into the patient's gastric lumen, one of the three sutures placed immediately broke.A new suture was placed and the procedure continued with no immediate complications.No additional information was provided.

• Common Device Name: DIGESTHEALTH ENTERAL FEED PERC PLACEMENT
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6298596
• Report Number: 9611594-2017-00019
• Device Sequence Number: 19234902
• Product Code: KGC
• UDI-Device Identifier: 10680651984330
• UDI-Public: 10680651984330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2017

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 Expiration Date: 04/01/2018
• Device Model Number: 98433
• Device Catalogue Number: 991098433
• Device Lot Number: AA6123R05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/02/2017
• Patient Sequence Number: 1