MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC STANDARD PEG KIT - PUSH METHOD; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	7150-20
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 06 may 2021 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 inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Fda user facility report # (b)(4) was received on 14-apr-2021, and the following information was provided: "according to interventionalist complication fracture of the existing gastrostomy tube with retained internal bumper." the original intended procedure was "g [gastrostomy] tube was being changed.Inserted on (b)(6) 2020 [(b)(6) 2020]." "this was a planned procedure." no patient injury was reported.Additional information has been requested but not yet received.

• Brand Name: MIC STANDARD PEG KIT - PUSH METHOD
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11787654
• Report Number: 3006646024-2021-00006
• Device Sequence Number: 14363945
• Product Code: KNT
• UDI-Device Identifier: 00350770409764
• UDI-Public: 00350770409764
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 7150-20
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR