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

Model Number	40-7361
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 22 may 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.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 inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the "patient had ngt [nasogastric tube] and tracheostomy in situ.Patient had tracheostomy changed.During the tracheostomy change, ngt came out.On inspection, ngt had missing tip that appeared balloon-like and half cut.Medical team informed.Portable abdominal x-ray performed and tip noted to be visible inside patient's stomach.Decision made not to mechanically retrieve tip.Patient was not harmed." additional information received 12-may-2020 indicated the ngt was in use for 5 days.The customer stated "the tracheostomy would not have resulted in the ngt being cut or broken, as it was the distal 5cm that was broken, and this was well inside the patient's gastrointestinal cavity at the time of the tracheostomy change.".

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTO
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10083843
• Report Number: 9611594-2020-00084
• Device Sequence Number: 2861105
• Product Code: KNT
• UDI-Device Identifier: 10680651460292
• UDI-Public: 10680651460292
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2020

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: 40-7361
• Device Catalogue Number: 104602900
• 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: 05/01/2020
• Initial Report FDA Received Date: 05/22/2020
• Patient Sequence Number: 1
• Patient Age: 31 YR