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

Model Number	PFTS6.5P-EO
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Correction: medwatch report number.The information previously submitted in 9611594-2023-00116 was intended to be submitted under 3011270181-2023-00116.No further information will be submitted under 9611594-2023-00116.A new initial medwatch will be submitted under 3011270181-2023-00116.All information reasonably known as of 12 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.H3 other text : device not returned.

• Brand Name: NEOMED POLYURETHANE FEEDING TUBES (NON 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 17636022
• Report Number: 9611594-2023-00116
• Device Sequence Number: 6339435
• Product Code: BSS
• UDI-Device Identifier: 00350770002194
• UDI-Public: 00350770002194
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: PFTS6.5P-EO
• Device Catalogue Number: N/A
• Device Lot Number: TY220618
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown