MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 6FX60CM DUAL PRO LINE CT-BASIC; PRO-LINE® CT

Model Number	MR28036201
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.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.
Event or Problem Description
Notified by chemotherapy unit that pro-line leaking when flushed but not at connector, at junction where both lumens enter suture device (white lumen).Devices are never sutured, securacath used.
Additional Manufacturer Narrative
The 6f pro line was returned for evaluation with approximately 2.5 cm of lumen attached.Visual inspection of the device revealed the extension tubing with the white luer appears to have pulled out of the hub.The device was further evaluated by medcomp engineering.The hub was sectioned and measurements taken of the extension insertion depth.It was noted the tubing was not inserted into the hub to the specified depth.A supplier corrective action request was issued to the contract manufacturer for this event.The contract manufacturer's investigation revealed the root cause was failure to properly place the extension tubing onto the molding rod during the hub molding procedure.As a result, all personnel involved in this process were retrained to the procedure.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: 6FX60CM DUAL PRO LINE CT-BASIC
• Common Device Name: PRO-LINE® CT
• 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: 22019626
• Report Number: 2518902-2025-00024
• Device Sequence Number: 21193968
• Product Code: LJS
• UDI-Device Identifier: 00884908034622
• UDI-Public: (01)00884908034622(17)270117(10)MRBQ850
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/01/2025

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: MR28036201
• Device Catalogue Number: MR28036201
• Device Lot Number: MRBQ850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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: 80 YR
• Patient Sex: Male