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

Model Number 40-9438

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 26-dec-2019 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, inc.Complaint database and identified as complaint (b)(4).

Event Description

An fda user facility report, # (b)(4), was received on 02-dec-2019, and the following information was provided: patient's nasogastric tube became clogged with baclofen dose.Through troubleshooting, repositioning, and the use of coca-cola, the tube began to flush easily.Enteral lorazepam was administered without issue three hours later.At midnight a chest x-ray was obtained to assess patient lung fields due to difficulty keeping patient's oxygen saturations up.The x-ray showed a 1:1 segmental defect in the indwelling feeding tube.There was a break/discontinuity just beyond the gastroesophageal (ge) junction.The distal tube and tip were within the patient's stomach.When the feeding tube was pulled out, it was all in one piece with a clear portion of larger perforation.The tube was saved and photos provided.Patient did not experience harm but did have to have the tubing replaced.Patient was discharged on (b)(6) 2019.Additional information received 13-dec-2019 stated [we] cannot confirm how long the nasogastric (ng) tube was in place.There was no lot number.We don¿t believe any harm occurred as the patient was discharged on (b)(6) 2019, but tube had to be replaced.Date of event: (b)(6) 2019.

Manufacturer Narrative

One used sample device was received.No product packaging was received with the used sample device.The product did not contain a lot number.The device was evaluated, the failure was confirmed.A root cause was not identified.All information reasonably known as of 24-jan-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, inc.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 WITH ENFIT CONNECTOR
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9523211
• MDR Text Key: 198207639
• Report Number: 9611594-2019-00257
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651460506
• UDI-Public: 10680651460506
• Combination Product (y/n): N
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

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: 40-9438
• Device Catalogue Number: 104605001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR