MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NG/NI PEDIATRIC FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR; DH CPK ANTI-IV (AIV) FEEDING TUBES

Model Number	40-8368
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
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 30061584 was reviewed and the product was produced according to product specifications.All information reasonably known as of 13 oct 2021 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 complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the second of three reports.Refer to 9611594-2021-00144 for the first report.Refer to 9611594-2021-00146 for the third report.It was reported that the nurse went to check gastric contents to confirm placement, but was unable to.Resistance was met when trying to aspirate.Upon further inspection a hole was found near the enfit connection site.Per additional information received 28 sep 2021 it was clarified that the hole was on the distal portion of the tube that was inserted into the patient's stomach.

• Brand Name: CORFLO NG/NI PEDIATRIC FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR
• Common Device Name: DH CPK ANTI-IV (AIV) FEEDING TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12656509
• Report Number: 9611594-2021-00145
• Device Sequence Number: 1205913
• Product Code: KNT
• UDI-Device Identifier: 00350770460376
• UDI-Public: 00350770460376
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• 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): 10/19/2021

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: 06/25/2025
• Device Model Number: 40-8368
• Device Catalogue Number: N/A
• Device Lot Number: 30061584
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1