MAUDE Adverse Event Report: AVANOS MEDICAL INC. ENFIT PVC FEEDING TUBE ORANGE 6.5FR 60CM; DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)

Model Number	FTM6.5V-NC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Perforation of Esophagus (2399)
Type of Reportable Event	Serious Injury
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 17 aug 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.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).
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 3011270181-2020-00113 for the second report.It was reported that there was an incidence of esophageal perforation related to used of the device.The patient was born at (b)(6), weighing (b)(6) g, and a feeding tube was inserted after birth.A new tube was placed on day 4 and the patient was receiving feed.On day 5 a chest x-ray was performed noted that the tube was retracted to the level of the esophagus and advanced.The patient developed worsening ventilatory requirements, and the imaging showed concern for esophageal perforation into the right thoracic cavity.A chest tube was placed and pleural fluid output was consistent with gastric contents.Air was inserted into the tube and a pneumothorax was confirmed via chest x-ray.The patient was treated with zosyn, as the patient developed signs of sepsis.Testing of the pleural fluid showed growth of lactobacillus rhamnosus, which was most likely from probiotics given via the tube.Zosyn treatment lasted 7 days.After 14 days, esophagram showed no extravasation of contrast from the esophagus, and a slight narrowing of the esophagus at the level of the gastro-esophageal junction.The esophagus drained normally beyond this site.Another feeding tube was placed into the stomach without complication and the patient was discharged after four months of prolonged hospital stay.
Additional Manufacturer Narrative
The device history record for lot 20170730 was reviewed and the product was produced according to product specifications.All information reasonably known as of 29 sep 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 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: ENFIT PVC FEEDING TUBE ORANGE 6.5FR 60CM
• Common Device Name: DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10436695
• Report Number: 3011270181-2020-00112
• Device Sequence Number: 3974665
• Product Code: KNT
• UDI-Device Identifier: 00817584011434
• UDI-Public: 00817584011434
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K120182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 07/29/2020
• Device Model Number: FTM6.5V-NC
• Device Catalogue Number: N/A
• Device Lot Number: 20170730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 4 DA