MAUDE Adverse Event Report: AVANOS MEDICAL INC. NEOMED SILICONE FEEDING TUBES (NON ENFIT); DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)

Model Number	FTM8.0S-EO
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 01 feb 2023 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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.Device not returned.
Event or Problem Description
It was reported, the tube was found split inside the patient; the medical team retrieved the remaining tube from the patient without injury.There was no injury reported.
Additional Manufacturer Narrative
No further information concerning the reported event will be submitted using mw 3011270181-2023-00011; all future reports will be submitted using mw 3011270181-2023-00012 all information reasonably known as of 06 feb 2023 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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: NEOMED SILICONE FEEDING TUBES (NON ENFIT)
• Common Device Name: DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): NINGBO TIANYI MEDICAL APPLIANCE CO., LTD.; no.788,mozhi north rd; tourism resort; ningbo zhejiang, dongqian lake
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16284855
• Report Number: 3011270181-2023-00011
• Device Sequence Number: 4880841
• Product Code: FPD
• UDI-Device Identifier: 00350770002132
• UDI-Public: 00350770002132
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K072881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: FTM8.0S-EO
• Device Lot Number: TY210719
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 1 KG