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

Model Number	8180-20
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/16/2025
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, 30349239, 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 16-jul-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 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 "the patient came into clinic on monday, june 16 and the peg [percutaneous endoscopic gastrostomy] tube was removed per proper procedure.Unfortunately, the bumper broke off inside the patient.The patient was brought emergently to the cvor [cardiovascular operating room], where we performed an egd [esophagogastroduodenoscopy] and noted the bumper had already passed through.With a subsequent ct [computed tomography] scan, the bumper was found in the distal small intestine.[the clinicians] are closely monitoring the patient for potential ileocecal valve obstruction or if the patient passes the item." there was no reported injury.
Additional Manufacturer Narrative
Additional information: a2, a3a, a4, a5, a6, b5, e2, e3, e4, g2 and h6.All information reasonably known as of 01-apr-2026 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 mw report mw5172792 the following: patient came in for peg tube removal and during procedure the bumper broke off inside the patient.The patient had to be emergently taken to the or where an egd was performed.During the procedure it was determined that the bumper had already passed through further imaging revealed the bumper was in the distal email intestine.Patient was discharged with the education to come back to the hospital if symptoms of a bowel obstruction appeared.

• Brand Name: MIC SAFETY PEG KIT WITH ENFIT CONNECTORS - 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: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 22524392
• Report Number: 3006646024-2025-00017
• Device Sequence Number: 8633393
• Product Code: KNT
• UDI-Device Identifier: 00350770006581
• UDI-Public: (01)00350770006581(240)12000247(17)250801(10)30349239
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 08/01/2025
• Device Model Number: 8180-20
• Device Catalogue Number: 8180-20
• Device Lot Number: 30349239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White