MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC SAFETY PEG KIT - 20 FR - PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	7180-20
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 30266302, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 18-apr-2024 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, inc.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 not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
Event or Problem Description
It was reported via medwatch / fda user facility report 2300530000-2023-8040 the following information: doctor was performing a bedside percutaneous endoscopic gastrostomy (peg) procedure.While removing the retrieval snare, the snare broke off and doctor had to manually retrieve the item.What was the original intended procedure? : bedside peg procedure.

• Brand Name: MIC SAFETY PEG KIT - 20 FR - PULL
• 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19138822
• Report Number: 3006646024-2024-00016
• Device Sequence Number: 21182752
• Product Code: KNT
• UDI-Device Identifier: 00350770409795
• UDI-Public: 00350770409795
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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 Expiration Date: 02/28/2025
• Device Model Number: 7180-20
• Device Catalogue Number: N/A
• Device Lot Number: 30266302
• 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: 03/28/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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 Sex: Unknown