MAUDE Adverse Event Report: HALYARD HEALTH INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98433
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 27-nov-2017 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.(b)(4).
Event or Problem Description
Halyard received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the first of two reports.Refer to 9611594-2017-00153 for the second patient.It was reported that a physician had the sutures pulled up and locked in placed when four of the sutures broke.The first kit was replaced by a second kit.After the patient was transferred to the post-anesthesia care unit, the nurse reported that one suture broke from the second kit.It was noted that the sutures broke while the physician was closing the incision, and the stomach had to be re-insufflated.The physician stated that the procedure was prolonged as a result.It was noted that there was no patient injury.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 21-dec-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
Additional Manufacturer Narrative
Halyard health received a used gastropexy suture anchor.Also received is a scanned copy of one product label showing the reported lot number.The sample was received inside a sample bag.For the purpose of decontamination, the soft-shell was removed from the anchor base assembly.This was done to allow access to remove as much of the dried blood as possible.The sample has a partial suture attached and locked in the anchor.No damage was observed on the anchors.The sutures were not broken at the clamped area.The sample has approximately 1.5 - 2.0 length of suture extending from one end and approximately 1cm from the opposite end.The root cause of the reported issue could not be conclusively determined.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 09-jan-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7072385
• Report Number: 9611594-2017-00152
• Device Sequence Number: 19102479
• Product Code: KGC
• UDI-Device Identifier: 10680651984330
• UDI-Public: 10680651984330
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2017

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: 06/01/2019
• Device Model Number: 98433
• Device Catalogue Number: 991098433
• Device Lot Number: AA7184R12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 12/11/2017; 12/26/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/21/2017; 01/15/2018
• Patient Sequence Number: 1
• Patient Age: 50 YR