MAUDE Adverse Event Report: HALYARD HEALTH INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98432
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot aa8015r06 was reviewed and the product was produced according to product specifications.All information reasonably known as of 10 jul 2018 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).Device not returned.
Event or Problem Description
It was reported that after placement of the anchors, three of them did not stay fixed.Another kit was opened to complete the procedure.No further information provided.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 01 aug 2018 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).
Additional Manufacturer Narrative
Three sutures were received for evaluation.Each sample was received with the soft shell attached to the clamp base.None of the sutures showed signs of breakage.The complaint could not be confirmed as reported.The root cause could not be determined.All information reasonably known as of 14 sep 2018 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).

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7681128
• Report Number: 9611594-2018-00084
• Device Sequence Number: 646001
• Product Code: KGC
• UDI-Device Identifier: 10680651984323
• UDI-Public: 10680651984323
• 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,Followup,Followup
• Report Date (Section B): 08/28/2018

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: Other
• Device Expiration Date: 12/01/2019
• Device Model Number: 98432
• Device Catalogue Number: 991098432
• Device Lot Number: AA8015R06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 08/28/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/01/2018; 09/14/2018
• Patient Sequence Number: 1