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

Model Number	40-3551
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 30232489, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual device is reported to be available but has not been returned for evaluation.All information reasonably known as of 10-mar-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 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.Device not returned.
Event or Problem Description
It was reported the device broke at the end, "we think was due to use of clog buster." the patient had to be taken to the or [operating room] for retrieval of the remaining piece." there was no reported injury.
Additional Manufacturer Narrative
The product involved in the report was returned and processed for evaluation.The subject sample provided was evaluated confirming a tube clogged, the tubing appeared to have expanded to form a balloon shape which burst in multiple direction causing a separation of the tube into two pieces.The root cause of the reported issue could not be conclusively determined.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.All information reasonably known as of 20-apr2023 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 NGT/NASOINTESTINAL FEED TUBE, STYLET, ENFIT
• 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16522754
• Report Number: 9611594-2023-00038
• Device Sequence Number: 6572461
• Product Code: FPD
• UDI-Device Identifier: 00350770460178
• UDI-Public: 00350770460178
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K083210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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: 40-3551
• Device Catalogue Number: N/A
• Device Lot Number: 30232489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 14 MO
• Patient Sex: Male
• Patient Weight: 12 KG