MAUDE Adverse Event Report: AVANOS MEDICAL INC. ENFIT PU FEEDING TUBE PURP 6.5FR 60CM; DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)

Model Number	PFTM6.5P-NC
Medical Device Problem Codes	Material Discolored (1170); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The hospital has provided three possible lot numbers for the device involved, and reviews of the device history records are in-progress.All information reasonably known as of 19 aug 2021 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 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 that on (b)(6) 2021 the patient pulled out the oral gastric tube that had been placed on (b)(6) 2021.At the distal end of the tube, approximately 3cm before the end, there was a "defect the size of a pinhead." around the area of the defect was a 1cm area of yellowish discoloration.Per information provided by the facility, this event was witnessed and described by the patient's mother.The patient is described as being male, (b)(6) months old, and weighing (b)(6).

• Brand Name: ENFIT PU FEEDING TUBE PURP 6.5FR 60CM
• Common Device Name: DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12344915
• Report Number: 3011270181-2021-00045
• Device Sequence Number: 3834166
• Product Code: FPD
• UDI-Device Identifier: 00350770001791
• UDI-Public: 00350770001791
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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: PFTM6.5P-NC
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• 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: 08/02/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Weight: 3