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

Model Number 40-1368

Device Problems Material Rupture (1546); Stretched (1601)

Patient Problem Vomiting (2144)

Event Date 06/04/2023

Event Type  malfunction  

Event Description

It was reported, the nasogastric tube (ngt) was placed by interventional radiology on (b)(6) 2023.The patient vomited the tube on (b)(6) 2023, and part of it broke off in the patient¿s stomach.It was left there and another tube was placed in the infusion center that day.The broken part was eventually removed at a later date.Per additional information received on 17jul2023, it is unknown if the tube was ever clogged.Esophagogastroduodenoscopy with foreign body removal was performed on (b)(6) 2023.The patient recovered well.

Manufacturer Narrative

A review of the device history record is in-progress.The actual complaint product was not returned for evaluation.All information reasonably known as of 28 jul 2023 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 reported event but is relaying the information 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.

Manufacturer Narrative

A picture of the alleged device was provided, which confirmed the tubing expanded to form a balloon shape, which burst, causing a separation of the tube.The device history record for lot 30254527 was reviewed, and the product was produced according to product specifications.Per complaint comments, the tube was already used for 2 months, therefore, the failure reported might not be associated to the manufacturing process.Ifu contains recommendations for tube maintenance: ¿it is recommended the tube be irrigated every 4 hours with up to 20 ml of water (up to 10 ml for infants or children) before and after medication administration or when feeding formula is interrupted.Warning: vigorous syringe force should not be used to irrigate, administer liquids or unblock the tube.¿ a root cause could not be determined.All information reasonably known as of 25 sep 2023 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 reported event but is relaying the information 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 ENFIT CONNECTOR
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 17415195
• MDR Text Key: 320159101
• Report Number: 9611594-2023-00109
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770459998
• UDI-Public: 00350770459998
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-1368
• Device Catalogue Number: N/A
• Device Lot Number: 30254527
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 26 KG