MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. HICKMAN TRIFUSION CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	0609190
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Plastic piece of tunneler slipped off end of tunneler and had to be removed from under patients' skin with a hemostat.This is the second catheter that this has occurred.Reference report: mw5151886.

• Brand Name: HICKMAN TRIFUSION CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 18776824
• Report Number: MW5151885
• Device Sequence Number: 18230596
• Product Code: LJS
• UDI-Device Identifier: 00801741036521
• UDI-Public: 00801741036521
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2024

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 Expiration Date: 10/31/2025
• Device Model Number: 0609190
• Device Lot Number: REHY0762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEMOSTAT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male