MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR JEJUNAL/GASTRIC FEEDING TUBE, 22FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98438
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30060915 was reviewed and the product was produced according to product specifications.All information reasonably known as of 15 jun 2021 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 avanos medical complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 9611594-2021-00083 for the second report it was reported that the set of stays [sutures] had come dislodged within 24 hours of placement.Per the report, the "tube was moved and patient had gastric leak into peritoneum." additional information has been requested but not received.

• Brand Name: INTRODUCER KIT FOR JEJUNAL/GASTRIC FEEDING TUBE, 22FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12010939
• Report Number: 9611594-2021-00082
• Device Sequence Number: 19894430
• Product Code: KGC
• UDI-Device Identifier: 00350770984384
• UDI-Public: 00350770984384
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: 98438
• Device Catalogue Number: N/A
• Device Lot Number: 30060915
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention