MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q EXPANSION KITS, SILVERSOAKER ANTIMICROBIAL CATHETER, 2.5; CATHETERS

Model Number	PM010-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was 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.All information reasonably known as of 16-sep-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
Procedure: unknown cath place: intra-articular it was reported there was a silver soaker catheter "break off into a patient upon removal." the doctor did remove the remaining catheter surgically." additional information received 27-aug-2025 noted the "patient was taken back to the or (operating room) to remove the catheter (b)(6) 2025." a small incision was made at the skin and the entire catheter was removed with no issue.The "patient was removing the catheter and it snapped off.A portion of the distal end of the catheter remained inside the patient¿s knee." the catheter was secured on the patient via dermabond/ 2x2 and tegaderm.The patient experienced discomfort during the catheter removal.There was tension removing the catheter and it snapped." about six inches of the catheter was retained inside the patient.The catheter was removed on (b)(6) 2025.There was no reported injury.
Additional Manufacturer Narrative
The sample was received without the original packaging.Upon receipt, the portion of the catheter was placed inside a plastic container.The sample was sterilized prior to inspection and examination.No other components were received with the catheter.The entirety of the returned catheter was measured, and was measuring approximately 29.5 cm.Only the portion near 4 increments printed until the black end tip was returned.The catheter beyond this point towards the hub was not returned.When the break (near 4 increments print) was viewed under magnification, a jagged tearing effect was observed.The infusion segment was also measured and was measuring at 6.5mm.No obvious damage was observed to the infusion segment section as well as the black tip.The evaluation summary noted that there was damage on the silver soaker catheter, near the 4 increments print.The infusion segment appeared intact with no obvious defects.Root cause could not be determined.All information reasonably known as of 05-feb-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.

• Brand Name: ON-Q EXPANSION KITS, SILVERSOAKER ANTIMICROBIAL CATHETER, 2.5
• Common Device Name: CATHETERS
• 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.
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 23068942
• Report Number: 2026095-2025-00024
• Device Sequence Number: 15963579
• Product Code: BSO
• UDI-Device Identifier: 00193494135331
• UDI-Public: (01)00193494135331
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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 Model Number: PM010-A
• Device Catalogue Number: PM010-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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