MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR JEJUNAL/GASTRIC FEEDING TUBE, 20FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98437
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 25-jun-2020 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.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, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported "3 t-fasteners in the kit all broke upon insertion." there was no reported injury.Additional information received 11-jun-2020 stated, "all 3 sutures that were initially placed broke while advancing the serial dilator, displacing the stomach and introducing a large amount of free air." the patient had a positron emission tomography (pet) scan the following week which showed a large pneumoperitoneum, which was causing significant pain.

• Brand Name: INTRODUCER KIT FOR JEJUNAL/GASTRIC FEEDING TUBE, 20FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10201464
• Report Number: 9611594-2020-00111
• Device Sequence Number: 948958
• Product Code: KGC
• UDI-Device Identifier: 00350770984377
• UDI-Public: 00350770984377
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 06/26/2020

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 Model Number: 98437
• Device Catalogue Number: 109843702
• Device Lot Number: UNKNOWN
• 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: 06/03/2020
• Initial Report FDA Received Date: 06/26/2020
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 56