MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ENFIT CONNECTOR; DH CPK NG TUBES

Model Number	40-1362
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sinus Perforation (2277); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/16/2021
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 30107617 was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 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.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 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 9611594-2021-00078 for the second report.It was reported that a nasogastric (ng) tube was placed, without stylet, while the patient was awake and cooperative, and did not complaint of any pain, so that the ng tube was placed without difficulty.Placement confirmed via a kidney, ureter, and bladder x-ray (kub).The x-ray showed air in the abdomen, but the tube was shown to overlie the gastric body.A ct scan was ordered to assess the air in the abdomen, and showed that the ng tube had perforated the nasal pharynx.The tube was removed after given the ok by the cardio-thoracic surgical consult.Gastro-intestinal doctor consulted for placement of new tube, and there were no further complications.The patient was discharged to rehab.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ENFIT CONNECTOR
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11960006
• Report Number: 9611594-2021-00077
• Device Sequence Number: 19934323
• Product Code: KNT
• UDI-Device Identifier: 00350770459974
• UDI-Public: 00350770459974
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2026
• Device Model Number: 40-1362
• Device Catalogue Number: N/A
• Device Lot Number: 30107617
• 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: 05/20/2021
• Initial Report FDA Received Date: 06/08/2021
• 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
• Patient Age: 74 YR
• Patient Weight: 73