MAUDE Adverse Event Report: AVANOS MEDICAL INC. ENFIT PU FEEDING TUBE PURP 5FR 90CM; DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)

Model Number	PFTL5.0P-NC
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is in-progress.All information reasonably known as of 16 oct 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
Event or Problem Description
It was reported that the nasogastric (ng) tube kept migrating out of the patient.During the first migration incident, at 7:28pm, the infant patient was bearing down and the ng tube was "bowing out" about 3cm.The tube was put back into place.Later at 8pm the infant was found to be pulling on the tube.The tube was put back in place and re-taped with exuderm and endotracheal tube tape, which had been used twice for re-taping during the day shift.Then later again at 10:53pm the infant sneezed and the ng tube came almost all of the way out.The infant was swaddled, and could not pull on the tube with their hands.New tape was used to secure the ng tube.At 11:07pm the infant sneezed again and the ng tube came almost all the way out.Again the ng tube was put back in place, this time with the addition of tegaderm as an additional securement.There was no harm to the patient.
Additional Manufacturer Narrative
The device history record for lot 20200322 was reviewed and the product was produced according to product specifications.All information reasonably known as of 15 dec 2020 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.

• Brand Name: ENFIT PU FEEDING TUBE PURP 5FR 90CM
• 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: 10707783
• Report Number: 3011270181-2020-00123
• Device Sequence Number: 11047474
• Product Code: FPD
• UDI-Device Identifier: 00817584011748
• UDI-Public: 00817584011748
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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 Expiration Date: 03/21/2023
• Device Model Number: PFTL5.0P-NC
• Device Catalogue Number: N/A
• Device Lot Number: 20200322
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/16/2020
• Patient Sequence Number: 1
• Patient Age: 1 MO