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

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Perforation of Esophagus (2399); No Code Available (3191)

Event Type  Injury  

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 22 jul 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).

Event Description

Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 3011270181-2020-00105 for the second report.Refer to 3011270181-2020-00106 for the third report.It was reported that there was an esophageal perforation by the feeding tube during placement.The tube was being placed to help vent the stomach for an infant requiring respiratory support.The perforation was noted immediately on admission following placement of the tube.No further information regarding the event was provided.

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 18 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.

Event Description

Per additional information received on 30 jul 2020, the patient was born due to pre-term labor at 24weeks 1 day weighing 750g.The patient was intubated at birth and also had a feeding tube placed.On day 12 the patient was re-intubated and a new feeding tube was inserted.A chest x ray was performed and the tube was shown to be at the mid-abdominal instead of over the stomach, consistent with esophageal perforation.Patient was made no food by tube (npo) for 48 hours."within 24 hours, patient developed sepsis and hypotension and adrenal insufficiency.Antibiotics including cefotaxime/fluconazole/vancomycin and inotropes were started.Respiratory culture and blood cultures sent at that time were negative.Patient stabilized and a new feeding tube was placed and feeding was re-started.When the patient was aged 20 days, the patient's condition worsened and sepsis developed.Abdominal ultrasound showed left upper quadrant fluid collection near the splenic flexure of the colon and also loculated fluid over right hepatic lobe, consistent with intraabdominal abscess.We suspected that the abscess was formed due to esophageal leak as the location was consistent with the site of esophageal perforation.Infant was transferred to level iv neonatal intensive care unit (nicu) surgical unit.Infant was placed on prolonged antibiotics and prolonged npo.Abscess resolved.No surgery was needed.Infant tolerated full feeding now and remained on mechanical ventilation.

Manufacturer Narrative

H6 patient codes: adrenal insufficiency, abdominal fluid.All information reasonably known as of 19 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.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 comp-ghc-20-01906.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
• Type of Device: DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10320057
• MDR Text Key: 200230209
• Report Number: 3011270181-2020-00104
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00817584011434
• UDI-Public: 00817584011434
• Combination Product (y/n): N
• PMA/PMN Number: K120182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2020
• Device Model Number: FTM6.5V-NC
• Device Catalogue Number: 834051
• Device Lot Number: 20170730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN TRACHEAL TUBE
• Patient Outcome(s): Required Intervention
• Patient Age: 12 DA