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

Model Number	42-7366
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A definitive lot number was not provided.The device history record for potential lot 74943 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 04 may 2020 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 inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that "6fr weighted nj [nasojejunal] tube in situ.Patient pulled out tube and new tube replaced.On completion of xray it was noted that the weight of the tube had disconnected from the rest of the tube and remained in the jejunum.Patient passed the tube naturally and no surgical intervention was required." device was in use for 3 days.No patient injury was reported.Additional information received 20-apr-2020 indicated the exact lot number was unknown.The patient's current condition is "patient is currently home.".

• 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: 10022681
• Report Number: 3011270181-2020-00053
• Device Sequence Number: 16923388
• Product Code: KNT
• UDI-Device Identifier: 10350770460816
• UDI-Public: 10350770460816
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/04/2020

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: Lay User/Patient
• Device Model Number: 42-7366
• Device Catalogue Number: 104608100
• 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: 04/16/2020
• Initial Report FDA Received Date: 05/04/2020
• Patient Sequence Number: 1
• Patient Age: 17 MO
• Patient Weight: 8