MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE; DH CPK NI (NASOINTESTINAL) FEEDING TUBES

Model Number	20-5431
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
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 not possible as no lot number was provided.All information reasonably known as of 07 nov 2022 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).
Event or Problem Description
Avanos medical inc.Received a single report that referenced four different incidences, which were all associated with the same (one) unit, involving the same (one) patient.This is the third of four reports.See mw#: 9611594-2022-00134 for the first event.See mw#: 9611594-2022-00135 for the second event.See mw#: 9611594-2022-00137 for the fourth event.It was reported that the nasogastric tube (ngt) was sliding with the corgrip in place.The amt bridle pro was placed on (b)(6) 2022.On (b)(6) 2022, the nurse (rn) noted that the ngt was pulled out to the forty-five cm marking with amt bridle pro in place.An x-ray was performed, and an order was received that the ngt was ok to be used.No injury occurred.
Additional Manufacturer Narrative
Additional information: h6 type of investigation all information reasonably known as of 22 feb 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.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE
• Common Device Name: DH CPK NI (NASOINTESTINAL) FEEDING TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 15748964
• Report Number: 9611594-2022-00136
• Device Sequence Number: 6317382
• Product Code: KNT
• UDI-Device Identifier: 00350770457437
• UDI-Public: 00350770457437
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K821906
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 20-5431
• Device Catalogue Number: 104574300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 02/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMT BRIDLE PRO.
• Patient Age: 65 YR
• Patient Sex: Male