MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NG/NI FEED TUBE, STYLET, ENFIT CONNECTOR; DH CPK NG TUBES

Model Number	40-9226
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was an incident of the nasogastric tube fracturing during use while inside of the patient.Additional information received 29-feb-2024 stating the tube was indwelling for only 9-days.The patient had a chest x-ray for an unrelated issue which showed tip of tube missing.It was not noticed by clinical staff until the nurse practioner (np) reviewed x-ray on (b)(6) 2024.The remainder of tube was not visible on x-ray indicating that it may have been passed by the patient.The tube was removed and measured and confirmed 1cm of distal end was missing.The patient did not require medical intervention.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 15-may-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 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.
Additional Manufacturer Narrative
H6: investigation findings: 4247- appropriate term/code not available: usage problem identified.The actual complaint product was returned for evaluation.Subject sample provided was evaluated confirming a tubing appeared to have expanded to form a balloon shape which burst open causing the tube to break into 2 pieces and became thin in the surface.After examining the burst portion of tube, clogging in the tubing was identified.A hardened feeling was felt along the way, most predominantly at 48cm marking.The tubing was then cut open to inspect and examine the inner portion.Crystallized-like substance appearance was found when examined under magnification.Axial split, at the medial location of the split the material appears lighter and more stressed, causing the tube to be open and unable to use.However, this seems to be a user related problem since as per the instructions for use (ifu), vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.According to the evaluation this does not seem to be manufacturing device related.The root cause was related to user: inappropriate use.All information reasonably known as of 25 jun 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 NG/NI FEED TUBE, STYLET, ENFIT CONNECTOR
• Common Device Name: 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19335176
• Report Number: 9611594-2024-00081
• Device Sequence Number: 19598815
• Product Code: KNT
• UDI-Device Identifier: 00350770460383
• UDI-Public: 00350770460383
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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
• Operator of Device: Health Professional
• Device Model Number: 40-9226
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 3 KG