MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-20 INTRODUCER KIT; DH EF PERC PLACEMENT PRODUCTS

Model Number	98434-17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for aa6228r04 was reviewed and the product was produced according to product specifications.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 reported not available.
Event or Problem Description
Halyard received a single report that referenced two different incidences, which were associated with separate kits, involving the same patient during the same procedure.This is the second of two reports.Refer to 9611594-2017-00032 for the first report.It was reported that during a gastronomy tube placement, following the failure of the sutures from the first kit, sutures from a second kit were used.All of the sutures from the second kit also broke during placement.A total of six sutures from two kits were alleged to have broken.Another kit was used to complete the procedure.There was some stomach discharge during the procedure due to dermal perforation.No further information has been provided at this time.

• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6373031
• Report Number: 9611594-2017-00033
• Device Sequence Number: 577961
• Product Code: KGC
• UDI-Device Identifier: 10680651984347
• UDI-Public: 10680651984347
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: 98434-17
• Device Catalogue Number: 991098434
• Device Lot Number: AA6228R04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 03/02/2017
• Patient Sequence Number: 1