MAUDE Adverse Event Report: TELEFLEX INCORPORATED VSI; INTRODUCER, CATHETER

Model Number	IPN916039
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During venous access portion of the procedure, wire was difficult to thread through needle and upon removal of needle and wire, access wire became stuck and tip of wire broke off.

• Brand Name: VSI
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 16120918
• Report Number: 16120918
• Device Sequence Number: 8396485
• Product Code: DYB
• UDI-Device Identifier: 10841156107079
• UDI-Public: (01)10841156107079
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/01/2022
• Report Date (Section F): 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN916039
• Device Catalogue Number: 7267V
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 73 KG
• Date Report Sent to FDA: 12/01/2022