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

Model Number	10229
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample was returned and evaluated.One used one (1) used suture that was not returned with the original packaging.The returned sample was reviewed for breaks in the suture or the t-bar dislodgement from the suture.There were no breaks in the suture and the t-bar was still intact.This incident was not confirmed.A root cause could not be determined.The device history record (dhr) for the lot number, aa6200r09, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.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 (b)(4) 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 (b)(4) complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a (b)(4) product is defective or caused serious injury.
Event or Problem Description
It was reported by the nurse that, the t-fastener broke; however, the procedure was completed.No injury reported.No additional information provided.
Additional Manufacturer Narrative
All information reasonably known as of 05may2017 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).

• Common Device Name: DIGESTHEALTH ENTERAL FEED PERC PLACEMENT
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6435898
• Report Number: 9611594-2017-00052
• Device Sequence Number: 317825
• Product Code: KGC
• UDI-Device Identifier: 10680651102291
• UDI-Public: 10680651102291
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• 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,Followup
• Report Date (Section B): 04/11/2017

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: 07/01/2018
• Device Model Number: 10229
• Device Catalogue Number: 991010229
• Device Lot Number: AA6200R09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 05/08/2017
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 87