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 Anemia (1706); Death (1802); Hemorrhage, Intraventricular (1892); Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012); Sepsis (2067); Perforation of Esophagus (2399); Respiratory Failure (2484); No Code Available (3191)

Event Type  Death  

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 third of three reports.Refer to 3011270181-2020-00104 for the first report.Refer to 3011270181-2020-00105 for the second 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

Patient codes: pulmonary hypertension, cardiorespiratory failure.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 (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 30 jul 2020, patient was born pre-term with gestational age (b)(6) and weighed (b)(6).The patient was intubated at birth and a feeding tube placed.During insertion of the feeding tube, resistance was felt at 10cm.Chest x-ray showed that the tube overlaid the low thoracic esophagus.The tube was removed and a right pneumothorax was noted on a chest x-ray performed 30 minutes later.Order was made for patient to receive no food by mouth or feeding tube, the patient was started on broad spectrum antibiotics due to the pre-term labor.Esophageal perforation was suspected but not confirmed.Another feeding tube was placed when the patient was 6 days old, no complications and position was confirmed by chest x-ray.During the hospital course, patient also developed pulmonary hypertension, respiratory failure, sepsis, hypotension, anemia and severe intraventricular hemorrhage.Patient was withdrawn from support on day of life 9 due to cardiorespiratory failure.

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 comp-(b)(4).

• 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
• Manufacturer (Section G): NINGBO TIANYI MEDICAL APPLIANCE CO, LTD; no. 788, mozhi north road; dongqian lake, ningbo
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 10320053
• MDR Text Key: 200229688
• Report Number: 3011270181-2020-00106
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00817584011434
• UDI-Public: 00817584011434
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse
• 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
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2017
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 1 DA