MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NETUBE STY ENFIT,10FR,91CM,10; DH CPK NG TUBES

Model Number	42-7361
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, nutrition leaked from the tube on the same day.The tube was removed from patient.A tear was detected at 71cm mark.It was reported there were no sharp-edged tools used in conjunction with the device.There was no reported patient injury.
Additional Manufacturer Narrative
The actual device is reported to be available but has not been returned for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of 20-aug-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
The actual complaint product was returned for evaluation.All information reasonably known as of 03-oct-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
The device history record for the reported lot number, 30277240, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.There was no original packaging received with the tube.No other component returned as well.The returned sample device was infused with water to show a fluid pathway.There was leakage seen on the tubing.The tube was examined, there was a slit seen at 71cm marking.Under magnification (30x), there was a slicing, cutting effect on the yellow tubing that observed to be smooth on the surface.This area was circled with red marker.The circle red marker was seen upon receipt in the lab.The reported failure has been confirmed during sample evaluation, and it has been determined that the leakage was caused by a small hole located in 71cm marking.After reviewing the manufacturing process, it was found that the process controls were in place correctly and the personnel involved were adequately trained.Additionally, attempts to replicate the reported failure during the process were unsuccessful, therefore, this is unknow root cause.All information reasonably known as of 13-nov-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.

• Brand Name: CORFLO NETUBE STY ENFIT,10FR,91CM,10
• 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: 20020882
• Report Number: 9611594-2024-00169
• Device Sequence Number: 8674817
• Product Code: KNT
• UDI-Device Identifier: 00350770460802
• UDI-Public: (01)00350770460802(240)104608002(17)280820(10)30277240
• Combination Product (Y/N): N
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2024

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: 42-7361
• Device Catalogue Number: 42-7361
• Device Lot Number: 30277240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 10/15/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/04/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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 Sex: Unknown