MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET; DH CPK NG TUBES

Model Number 20-7438

Device Problem Break (1069)

Patient Problem Vomiting (2144)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and the investigation remains in progress.The device history record for lot 30061632 was reviewed and the product was produced according to product specifications.All information reasonably known as of 18 jan 2021 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).

Event Description

It was reported that the feeding tube ruptured inside the patient.The patient vomited the ruptured tube pieces out.Per additional information received 05 jan 2021, the feeding tube was in place for less than a day.There was no injury to the patient, and the feeding tube was not replaced.The tube had been placed for a colon cleanout preparation, and only clear solution, golytely, was administered through the tube for the purposes of colon cleanout.There had been no issues with clogging prior to the event.

Manufacturer Narrative

One used sample was returned for evaluation that was broken into parts.The broken distal end of the tube could not be flushed with water due to a blockage.There was also evidence of "ballooning" near the broken end.The tube was cut open and a dried white powdery substance was found inside.The complaint is confirmed as reported.The root cause is most likely use related.Per the instructions for use, vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 03 mar 2021 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: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11197233
• MDR Text Key: 240101898
• Report Number: 9611594-2021-00005
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770457611
• UDI-Public: 00350770457611
• Combination Product (y/n): N
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20-7438
• Device Catalogue Number: N/A
• Device Lot Number: 30061632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GOLYTELY
• Patient Age: 12 YR