MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12F X 20CM SILICONE SINGLE LUMEN CATHETER

Model Number	SSL1220ME.
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the disconnection of the dialysis, blood was collected from catheter with the luer lock-compatible carried out.Bubbling was observed in the branchs and air intake with blood beading the flexible outer wall of the femoral.
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The 12f silicone hemo-cath was returned for evaluation.Clarification of the event, including the location of the leak, was requested.However, customer could not provide the requested information.Visual inspection revealed a large amount of dried blood within the lumen.After decontamination the lumen was cleared.Functional testing was performed by clamping the distal end of the lumen with hemostats and flushing through the lumen.No leaks or other issues were noted.No problem found with returned device.No further investigation is necessary.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12F X 20CM SILICONE SINGLE LUMEN CATHETER
• Common Device Name: SILICONE SINGLE LUMEN
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 22210372
• Report Number: 2518902-2025-00038
• Device Sequence Number: 20997705
• Product Code: MPB
• UDI-Device Identifier: 00884908049541
• UDI-Public: (01)00884908049541(17)290809(10)MRKM940
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: Other
• Device Model Number: SSL1220ME.
• Device Catalogue Number: SSL1220ME.
• Device Lot Number: MRKM940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 93 KG