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

Model Number	FTM8.0P-NC
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/27/2023
Type of Reportable Event	Death
Event or Problem Description
Fda medwatch / fda user facility report mw report (b)(4) reported, ¿og (orogastric (og) tube) caused posterior pharynx perforation leading to pneumomediastinum.Patient born via c-section.Admitted to [neonatal intensive care unit] nicu and og was inserted by [registered nurse] rn.Met resistance and unable to advance.Smaller og was inserted to 10 cm by another rn but unable to be advanced further.On chest x-ray, mediastinal air and air tracking up to neck seen.[ear nose and throat] ent performed evaluation with camera, demonstrating og perforated through posterior pharynx.Og was removed.¿ fda user facility report mw report (b)(4) additionally reported, ¿per note from medical director: this was a patient with high risk for cardiopulmonary demise based on perinatal circumstances of early and prolonged preterm rupture of membranes.Although the esophageal perforation did result in pneumomediastinum, the chest x-rays demonstrated no appreciable lung expansion despite maximal ventilator support.This infant's care was redirected as a result of the latter, and i do not believe the og perforation contributed significantly to the death.¿.
Additional Manufacturer Narrative
4581-appropriate clinical signs, symptoms, conditions term/code not available: pneumomediastinum.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 jun 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.
Additional Manufacturer Narrative
The actual sample from the reported event was not returned for evaluation; therefore, five retained samples from the reported lot were used to perform the retained sample inspection.Visual examination of the devices revealed the tubes appeared smooth and free of flashing, burrs, bubbles and specks.Testing of the device(s) was performed: the tubes were filled with water, the caps closed, and the tubes were suspended upside down for five minutes; no backflow or leakage was noted during testing.A pressure test was performed and the tubular portion, junction between the hub and tubing was held under tensile force of 20mm/min and the test results met all requirements.Additionally, the tubes were measured, and all measurements were within specification(s).The reported event could not be confirmed as reported, the root cause is undetermined.The device history record for lot ty210705 was reviewed and the product was produced according to product specifications.All information reasonably known as of 27 jun 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: DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)
• Common Device Name: NEOMED POLYURETHANE FEEDING TUBES (ENFIT)
• 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,
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 17043484
• Report Number: 3011270181-2023-00057
• Device Sequence Number: 8784139
• Product Code: FPD
• UDI-Device Identifier: 00350770000626
• UDI-Public: 00350770000626
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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: 07/04/2024
• Device Model Number: FTM8.0P-NC
• Device Lot Number: TY210705
• Was Device Available for Evaluation?: No
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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; Life Threatening
• Patient Sex: Male