MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 7F X 60CM DUAL PRO LINE CT; PRO-LINE CT

Model Number MR28037201

Device Problem Leak/Splash (1354)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/14/2024

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

The patient was undergoing a bone marrow transplant.Central line inserted.Blood loss noted from tunnel.Ultrasound showed right jugular vein thrombosis.Ct of the chest showed an increase in diameter of the right internal jugular vein and the lumen is occupied by material inhomogeneous, spontaneously hyperdense on basal scans and it its context small gas bubbles, indicative of thrombus.Anticoagulant therapy started with low molecular weight heparin.Catheter was removed and found to have a fissure.

• Brand Name: 7F X 60CM DUAL 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: 18969777
• MDR Text Key: 338551002
• Report Number: 2518902-2024-00020
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00884908034646
• UDI-Public: 00884908034646
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MR28037201
• Device Catalogue Number: MR28037201
• Device Lot Number: MQZQ620
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• 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