MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5FX60CM SNGL PRO LINE CT; PRO-LINE CT

Model Number	MR28035101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Loss of saline solution from the hub was noted during use at both catheter lumens.There is no loss from the hub with nfc connected to the catheter.Device used for drug infusion and parenteral nutrition.Event occurred on the first use.Device was removed and a new device implanted.
Additional Manufacturer Narrative
Additional information provided indicated the device involved in this event is not a medcomp product.

• Brand Name: 5FX60CM SNGL PRO LINE CT
• Common Device Name: PRO-LINE CT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 18319642
• Report Number: 2518902-2023-00076
• Device Sequence Number: 7250603
• Product Code: LJS
• UDI-Device Identifier: 00884908034608
• UDI-Public: 00884908034608
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/15/2023

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: Other
• Device Model Number: MR28035101
• Device Catalogue Number: MR28035101
• Was Device Available for Evaluation?: No
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown