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

Model Number FTS6.5P-EO

Device Problem Material Puncture/Hole (1504)

Patient Problem Bradycardia (1751)

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 10 aug 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 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, ¿infant was continuing to have bradycardia and was intolerant of feeds whenever anything was introduced to the feeding tube.A lot of air was being aspirated at a time.Staff had troubleshot every other potential cause of bradycardia and x-ray was performed.Suspected a hole present in gastric tube.Tube swabbed and found a hole on the tube.New tube was placed, and babe [infant] greatly improved.¿ per additional information received on 4aug2023, the tube was in place for less than 12 hours.The hole was noted at the 11 cm mark.The x-ray results showed ¿tube in good position however very small gastric bubble noted (did not align with amount of air being aspirated).¿ the tube was not clogged prior to this incident occurring.

Manufacturer Narrative

The product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 19 sep 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 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.

Manufacturer Narrative

Correction: d2, d4.All information reasonably known as of 03 nov 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 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.

Manufacturer Narrative

H6: investigation findings: appropriate term/code not available: malfunction observed without conclusive finding.The device history record for lot ty220618 was reviewed, and the product was produced according to product specifications.Five manufacturer-retained samples from the same lot number were tested.No abnormalities were noted during testing.The actual complaint product was returned for evaluation.When the tube was infused with water to show a fluid pathway, there was leakage seen at the 11cm marking.The tube was examined under magnification (30x), there was a slit/ opening identified.The area where the slit/opening located appeared slightly jagged with cutting effect.The incident was confirmed based on sample evaluation.A root cause could not be determined.All information reasonably known as of 26 dec 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 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: NEOMED POLYURETHANE FEEDING TUBES (NON ENFIT)
• Type of Device: 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 17772542
• MDR Text Key: 323700818
• Report Number: 3011270181-2023-00116
• Device Sequence Number: 1
• Product Code: FPD
• UDI-Device Identifier: 00350770002194
• UDI-Public: 00350770002194
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K082238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/27/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FTS6.5P-EO
• Device Catalogue Number: N/A
• Device Lot Number: TY220618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• 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