MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPICC PROVENA FT CATHETER WITH SOLO VALVE TECHNOLOGY; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S1295108FD1
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Needle would not allow guidewire to advance through during a picc line insertion.

• Brand Name: POWERPICC PROVENA FT CATHETER WITH SOLO VALVE TECHNOLOGY
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 17585206
• Report Number: MW5144778
• Device Sequence Number: 12333207
• Product Code: LJS
• UDI-Device Identifier: 00801741154805
• UDI-Public: (01)00801741154805
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/15/2023

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: 04/30/2024
• Device Catalogue Number: S1295108FD1
• Device Lot Number: REHQ3544
• 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: 08/18/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic