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

Model Number 42-9226

Device Problems Complete Blockage (1094); Stretched (1601); Material Split, Cut or Torn (4008)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Date 04/10/2023

Event Type  malfunction  

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 23 may 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.H3 other text : device not returned.

Event Description

It was reported that the corflo nasogastric/ nasointestinal feeding tube was placed nasojejunally.The tube had been in approximately six months and had been difficult to flush not long before the incident; the daughter had felt uncomfortable.They had managed to remove the blockage.As the tube had been in for six months ¿ the parents were advised to have the tube replaced.On removal of the nasojejunal (nj), the tube split, leaving a considerable amount within the patient.They were then transferred to the hospital for endoscopy under anesthetic to remove the remaining tube.No injury reported.The patient was discharged home.

Manufacturer Narrative

Correction: d4, h10.A review of the device history record is not possible as a valid lot number was provided.Additional information: h6, h10.A picture of the alleged device was provided.The picture provided confirms tubing expanded to form a balloon shape which burst causing a separation of the tube; however, a root cause could not be conclusively determined.Per complaint comments, the tube was already used for 6 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.¿ all information reasonably known as of 12 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 STYLET 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: 17004075
• MDR Text Key: 315966173
• Report Number: 9611594-2023-00076
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460864
• UDI-Public: 00350770460864
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 42-9226
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 14 MO
• Patient Sex: Female