MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	7180-20
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via maude adverse event report / mdr report key (b)(4), "peg was pulled "bed-side".The internal bumper on the peg broke off into the pt's stomach and passed the pylorus.A kidney, ureter, and bladder test (kub) was obtained showing the bumper in the small bowel and subsequently at the ileocecal valve vs cecum, an x-ray was done, and the bumper was seen in the cecum.A colonoscopy was performed, and the bumper was successfully removed.".
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.A root cause could not be determined.All information reasonably known as of 24 mar 2025 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 (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: MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson AZ 85756
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 21691694
• Report Number: 3006646024-2025-00007
• Device Sequence Number: 18461953
• Product Code: KNT
• UDI-Device Identifier: 00350770006178
• UDI-Public: (01)00350770006178
• Combination Product (Y/N): N
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: 7180-20
• Device Catalogue Number: 7180-20
• 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: 02/26/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian