MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO PEG KIT WITH ENFIT CONNECTOR; DH CPK PEG INITIAL PLACEMENT PRODUCTS

Model Number	50-6012E1
Medical Device Problem Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was originally reported that the corflo peg tube had dislodged from the patient.Per additional information received 13 apr 2022, images were received that showed that the peg bumper had broken off.Per additional information received 14 apr 2022, there was no medical intervention required, however the reporter did not know if the bumper had passed through the patient naturally.The patient's current condition was described as "well." no further information has been provided at this time.
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 not possible as no lot number was provided.All information reasonably known as of 04 may 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).Device not returned.

• Brand Name: CORFLO PEG KIT WITH ENFIT CONNECTOR
• Common Device Name: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 14311269
• Report Number: 2026095-2022-00048
• Device Sequence Number: 14780852
• Product Code: KNT
• UDI-Device Identifier: 00350770462042
• UDI-Public: 00350770462042
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

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: 50-6012E1
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/06/2022
• 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: Male