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

Model Number	FTS5.0P-EO
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units.This is the first of three reports.Refer to 3011270181-2023-00131 for the second report.Refer to 3011270181-2023-00132 for the third report.It was reported, nasogastric tube (ngt) mal positions.Three insertion attempts were made, and all were mal-positioned.Patient oral feeding was delayed by about a week.No long-term adverse patient impact expected.Exact location of malposition not reported.
Additional Manufacturer Narrative
The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 13 nov 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 reported event but is relaying the information 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.H3 other text : device not returned.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 the product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 13 dec 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 reported event but is relaying the information 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)(6).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.
Additional Manufacturer Narrative
All information reasonably known as of 13 feb 2024 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 reported event but is relaying the information 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.
Event or Problem Description
Per additional information received on 17jan2024, ¿the tube malposition was confirmed through x-ray and there is no more information available.¿.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.Tube was returned with medical tape attached into the tubing between 13-14cm marking.It was removed and inspected; no obvious defects seen.An adhesive residue was observed on the tubing surface.During inspection of the entirety of the tubing, there were no visible abnormalities seen such as kinks, cut/ tear, deformation and burr/ flashing.A root cause could not be determined.All information reasonably known as of 23 apr 2024 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 reported event but is relaying the information 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 POLYURETHANE 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, dongqian lake; ningbo zhejiang, cn
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18135416
• Report Number: 3011270181-2023-00130
• Device Sequence Number: 6553507
• Product Code: FPD
• UDI-Device Identifier: 00350770002187
• UDI-Public: 00350770002187
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/25/2024

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 Model Number: FTS5.0P-EO
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 01/17/2024; 04/09/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/14/2023; 02/14/2024; 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown