MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER15, 135CM; CATHETER, CONTINUOUS FLUSH

Model Number	700115-EU
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that the atraumatic tip of cleaner broke off in the patient.The sample device was discarded.
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.No samples were returned from the customer for review.Additionally, no photographic or visual evidence of any kind was provided, which would have allowed the allegation to be reviewed.Without necessary evidence, we are unable to perform a thorough investigation or determine a root cause and corrective action currently.As a result, no corrective action is required at this point.However, if samples are returned later, we would be happy to reopen this complaint for re-evaluation.

• Brand Name: CLEANER15, 135CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75758 ; 9036759321
• MDR Report Key: 23735979
• Report Number: 0001625425-2025-01153
• Device Sequence Number: 12947877
• Product Code: KRA
• UDI-Device Identifier: 00886333222339
• UDI-Public: (01)00886333222339(17)280505(10)REF250030/1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141617
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 700115-EU
• Device Lot Number: REF250030/1
• Was Device Available for Evaluation?: No
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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: Other
• Patient Sex: Unknown