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

Model Number MR28035101

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2023

Event Type  malfunction  

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 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.

Manufacturer Narrative

Additional information provided indicated the device involved in this event is not a medcomp product.

• Brand Name: 5FX60CM SNGL PRO LINE CT
• Type of Device: 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
• MDR Text Key: 330953290
• Report Number: 2518902-2023-00076
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00884908034608
• UDI-Public: 00884908034608
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention