MAUDE Adverse Event Report: AVANOS MEDICAL INC. NEOMED POLYURETHANE FEEDING TUBES (ENFIT); DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)

Model Number	PFTS5.0P-NC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional 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 16 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 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 or Problem Description
It was reported, ¿when changing the baby¿s diaper 1.5 cm of a tube was found in the stool.On inspection it looked like the tip of a gastric tube.I showed the father and called dr to the bedside.We removed the neomed enfit 5 fr nasogastric (ng) tube and the tip was missing.The piece in the diaper was the tip of the ng tube.A new neomed enfit 5 fr ng tube was placed.On review, it was found that the ng tube in question was placed on (b)(6) 2024.The manufacture recommendation is the tube should be changed out on or before 30 days.¿ the tube was removed and replaced.
Event or Problem Description
Per additional information received on 02may2024, there was no history of clogging.No crushed medications were administered via the tube.Syringe sizes used were 5ml to 60ml.The patient was discharged home two days later.
Additional Manufacturer Narrative
All information reasonably known as of 20 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 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.
Additional Manufacturer Narrative
Udi-pi is unavailable as no lot number was provided for the reported event.No new information was received on 18-jul-2024 from fda medwatch/ user facility report number 4600210000-2024-8007.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.
Additional Manufacturer Narrative
The sample device was evaluated.The returned sample device (feeding tube) was received without the original packaging.Upon receipt, the tube appeared dirty, with brownish build-up around the port.Also noticed was a little piece of tube that looks like broke off/ separated from the entirety of the feeding tube.The sample was decontaminated.The tubing was flushed with tergazyme and metricide solution using an enfit syringe in an attempt to clean the device.Some build-up from the port were flushed out.Some build-up from the inside of tubing was flushed out as well with slight resistance.After decontamination, the entirety of the sample was examined.It was evident that a portion of the tubing (towards the distal end) broke off, separated from the tubing.Approximately 2.0 cm total length broke off.When the breaking points of the tube was reviewed under magnification (50x), jagged tearing effects were seen.The tip end portion of the 2.0 cm tube did not appear to be damaged.There was dried build-up and discoloration (from the inner of tubing) observed on the 2.0cm tube as well.Root cause could not be determined.All information reasonably known as of 24-oct-2025 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: NEOMED POLYURETHANE FEEDING TUBES (ENFIT)
• Common Device Name: DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): NINGBO TIANYI MEDICAL APPLIANCE CO., LTD; no.788,mozhi north rd; tourism resort, dongqian lake; ningbo zhejiang, cn
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19343541
• Report Number: 3011270181-2024-00058
• Device Sequence Number: 15239524
• Product Code: FPD
• UDI-Device Identifier: 00350770001753
• UDI-Public: (01)00350770001753
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K082238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/24/2025

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: PFTS5.0P-NC
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 05/02/2024; 07/18/2024; 09/26/2025
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 05/20/2024; 08/06/2024; 10/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5ML TO 60ML SYRINGES.
• Patient Sex: Female
• Patient Weight: 3 KG