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

Model Number	98434-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
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 (b)(6) 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).
Event or Problem Description
It was reported that 2 t-fasteners broke after placement.Only 2 of the 4 fasteners were used, and both broke after the dilator was in place.The physician ended up placing the feeding tube without the use of the t-fasteners.There was no patient injury or intervention required.
Additional Manufacturer Narrative
Halyard health received two (2) sutures (gastropexy needle) that were returned without the original case packaging.They were returned in the gastropexy tray with no product label/information returned.The outer needle shield exhibited slight staining (brownish) color.The two returned sutures, which were identified by the customer/user as being unused, were still decontaminated due to the fact that they were received inside a biohazard bag.The complaint description also identified that the two unused sutures would be returned as representative samples.After decontamination, the two returned sutures were inspected and did not exhibit any suture break.The appearance of the returned unused sutures noticed to be damaged free.The broken sutures that were mentioned in the complaint description were not returned to the manufacturer.The root cause of the reported issue could not be conclusively determined since the broken sutures that were mentioned in the complaint description were not returned to the manufacturer, only two unused sutures were received.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 27-jun-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
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7501862
• Report Number: 9611594-2018-00066
• Device Sequence Number: 13501206
• Product Code: KGC
• UDI-Device Identifier: 10680651984347
• UDI-Public: 10680651984347
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: Physician
• Device Expiration Date: 08/01/2019
• Device Model Number: 98434-02
• Device Catalogue Number: 991098434
• Device Lot Number: AA7254R06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/27/2018
• Patient Sequence Number: 1
• Patient Age: 46 YR