MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO WITH STYLET; DH CPK NG TUBES

Model Number 20-9551

Device Problems Partial Blockage (1065); Break (1069); Material Integrity Problem (2978)

Patient Problem Vomiting (2144)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

It was reported that the distal end of the tube remained in a (b)(6) male patient, weighing (b)(6) pounds with a body mass index (bmi) of (b)(6), after a procedure to remove the tube from the patient; the tube was inserted into place on (b)(6) 2021.It is reported that on (b)(6) 2021 an x-ray with contrast confirmed the ruptured tube.It was reported that on (b)(6) 2021 that the fractured tube was removed and on (b)(6) 2021 the fractured remains of the tube were extubated by esophagogastroduodenoscopy (egd); at the time of this report, both pieces of the tube were recovered.It was reported, on (b)(6) 2021, that prior to the tube fracturing, the tube was noted to be clogged and had to be de-clogged with an enzymatic clog removal solution, via syringe.It was also reported that the patient vomited a brown liquid, on an unspecified date and had to have an orogastric tube (og) placed to drain the collection of fluid from his stomach.It was reported that on (b)(6) 2021, the family of the patient requested comfort measures only (cmo) and that the patient "ceased to breath" on (b)(6) 2021.It was reported that the cause of death was due to multi-system failure related to covid pneumonia.

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 in-progress.All information reasonably known as of (b)(6) 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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, inc.Complaint database and identified as (b)(4).

Manufacturer Narrative

A used sample was received.It was determined the sample was used in a patient with covid pneumonia.The sample was disposed of without evaluation.All information reasonably known as of 25 jan 2022 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.H3 other text: sample was contaminated and discarded.

• Brand Name: CORFLO WITH STYLET
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12968548
• MDR Text Key: 283694712
• Report Number: 9611594-2021-00182
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770458137
• UDI-Public: 00350770458137
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20-9551
• Device Catalogue Number: N/A
• Device Lot Number: 30137721
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 98 KG