MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO PEG JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR; DH CPK JEJUNOSTOMY PRODUCTS

Model Number	50-7366
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 25 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.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 inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the device was removed via traction and the internal bumper separated from the peg tube and was retained.There was a split in the tube close to skin level.No patient injury or medical treatment was reported.The device was inserted in (b)(6) 2020.Additional information received 16-aug-2021 indicated "on traction removal of a patient's corflopeg tube the internal bumper separated from the peg tube and was retained in the stomach.Patient to be monitored for signs of obstruction and if experiences any abdominal pain, abdominal distention, nausea, vomiting, altered bowel habits to arrange an urgent medical/hospital review.'" additional information received 17-aug-2021 indicated "during removal of peg tube, internal bumper came detached from peg tube and was retained in patient." further additional information has been requested but not yet received.

• Brand Name: CORFLO PEG JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR
• Common Device Name: DH CPK JEJUNOSTOMY PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12367136
• Report Number: 9611594-2021-00113
• Device Sequence Number: 4536637
• Product Code: KNT
• UDI-Device Identifier: 00350770462271
• UDI-Public: 00350770462271
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K821906
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 50-7366
• 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: 08/06/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR