MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 11.5FX15CM TRI-FLOW; TRI-FLOW CATHETER

Model Number XTP3116MT-J

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2019

Event Type  malfunction  

Event Description

The infusion extension separated from the catheter hub.

Manufacturer Narrative

The device contract manufacturer's investigation concluded that the central extension separated from the hub because the distal extension was not inserted far enough into the molding cavity.Isolated incident.

• Brand Name: 11.5FX15CM TRI-FLOW
• Type of Device: TRI-FLOW CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8874293
• MDR Text Key: 159369178
• Report Number: 2518902-2019-00049
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00884908060560
• UDI-Public: 884908060560
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: XTP3116MT-J
• Device Catalogue Number: XTP3116MT-J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR