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

Model Number 40-9558

Device Problem Crack (1135)

Patient Problem Vomiting (2144)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and the investigation remains in progress at this time.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2024 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.

Event Description

It was reported, that on (b)(6) 2024, a nasojejunal (nj) tube was placed on patient.On (b)(6) 2024, the patient started vomiting.Patient brought in to replace nj tube.While replacing nj, it was noticed that the nj had a crack in it.The part that had the crack would have been in the patient's stomach.Tube removed and new one was placed without incident.The patient endured more radiation to place the new tube, but no patient injury occurred.

Manufacturer Narrative

H6: investigation findings: 4247- appropriate term/code not available: malfunction observed without conclusive finding h6: investigation findings: 4247- appropriate term/code not available: blockage identified the actual complaint product was returned for evaluation.Ballooning and rupture of the tubing was observed at the 39cm depth marker.However, per incident comments, the device was in use for an extended period of time (15 to 30 days); which, indicates that device did not show this defect at time of placement and the tube performed as intended.A root cause could not be determined.All information reasonably known as of 11 apr 2024 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 W/ STYLET W/ 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 84048 ; MX 84048
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18969926
• MDR Text Key: 339333799
• Report Number: 9611594-2024-00045
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460543
• UDI-Public: 00350770460543
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 40-9558
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 5 YR
• Patient Sex: Female