MAUDE Adverse Event Report: AVANOS MEDICAL INC. ENTERAL DEVICE DECLOGGING SYSTEM; DH CPK CLOG ZAPPER ACCESSORIES

Model Number	20-0002
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 component code: solution.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.The lot number was not provided by the customer.Root cause could not be determined.All information reasonably known as of 23-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 a nurse having some splash in her eye from the clog zapper solution.Additional information received 30-jun-2025 the nurse attended the emergency department (ed) on advice from the poisons information centre.The advice was to go to ed and get triaged.The trauma provider did a litmus test which brought an abnormal reading.The treatment in ed involved a "local anesthetic to both eyes and an osmotic irrigation solution to draw out any chemicals in the eyes until the litmus reading is acceptable.Then eyes examined for damage plus follow-up appointment in outpatients."the nurse was wearing glasses but was looking down while reading the instructions to a second nurse doing the procedure and the solution sprayed into the eyes." no injury was sustained.

• Brand Name: ENTERAL DEVICE DECLOGGING SYSTEM
• Common Device Name: DH CPK CLOG ZAPPER ACCESSORIES
• 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: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 22579525
• Report Number: 2026095-2025-00019
• Device Sequence Number: 20840341
• Product Code: KNT
• UDI-Device Identifier: 00350770456096
• UDI-Public: (01)00350770456096
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K970178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 20-0002
• Device Catalogue Number: 20-0002
• 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: 06/05/2025
• Initial Report FDA Received Date: 07/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female