MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q CATHETERS-SILVERSOAKER

Model Number	PM050-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 30 jun 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 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, doctor removed catheter from a rib fracture patient but did not see the black tip.Ct performed and confirmed the catheter had broken off in the patient.The retained portion was removed successfully.Patient was reported to be doing well and was planning on being discharged the next day.Per additional information received on 9jun2025, the catheter broke inside of the patient.The catheter was not sutured.The catheter was secured to the patient with dermabond, steri-strips and two tegaderms.Moderate resistance was met when attempting to remove the catheter.The retained portion of the catheter was removed surgically on (b)(6) 2025.Removal was performed above the scapula, direct cut down with ultrasound prove guidance.
Additional Manufacturer Narrative
One used partial catheter was received and reviewed.After sterilization, the catheter was examined in a well-lit area.The overall length of the returned segment measures approximately 20.3cm.It did contain the infusion segment and distal black tip.The proximal portion of the catheter was not returned.The break was approximately 5mm above the thick black marker.There was a slight, set bend located approximately 2cm from the distal tip.The infusion segment did not exhibit damage.The area of the break was examined under magnification.It appeared pinched.The end was jagged.Root cause could not be determined.All information reasonably known as of 24-oct-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.

• Brand Name: ON-Q CATHETERS-SILVERSOAKER
• 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: 22373775
• Report Number: 2026095-2025-00015
• Device Sequence Number: 4388927
• Product Code: BSO
• UDI-Device Identifier: 00193494135416
• UDI-Public: (01)00193494135416
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: PM050-A
• Device Catalogue Number: PM050-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 10/24/2025
• 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