MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE; DH EF PERC PLACEMENT PRODUCTS

Model Number	98431
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is in-progress.All information reasonably known as of 23 may 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc.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
Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different patients.This is the fourth of four reports.Refer to 9611594-2019-00101 for the first report.Refer to 9611594-2019-00102 for the second report.Refer to 9611594-2019-00103 for the third report.It was reported that "t-anchors tear in part already at the placement or shortly after setting the t-anchor (within days)." no patient injury reported.Event occurred within the "last two months." additional information received on 08-may-2019 indicated that a new kit was opened to complete the case.
Additional Manufacturer Narrative
Additional information was received 03-may-2019, not 08-may-2019 as indicated on the initial report.The device history record for lot aa7191r03 was reviewed and the product was produced according to product specifications.The root cause could not be determined.All information reasonably known as of 26 jun 2019 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.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).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 an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8637793
• Report Number: 9611594-2019-00104
• Device Sequence Number: 11246782
• Product Code: KGC
• UDI-Device Identifier: 10680651984316
• UDI-Public: 10680651984316
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 06/01/2019
• Device Model Number: 98431
• Device Catalogue Number: 991098431
• Device Lot Number: AA7191R03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/26/2019
• Patient Sequence Number: 1