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

Model Number	S1395108D
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Bard powerpicc provena stylet broke.Fda safety report id# (b)(4).

• Brand Name: BARD POWERPICC PROVENA CATHETER WITH SOLO VALVE
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C. R. BARD, INC. / BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 13710932
• Report Number: MW5107956
• Device Sequence Number: 20041015
• Product Code: LJS
• UDI-Device Identifier: 00801741112751
• UDI-Public: (01)00801741112751
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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 Expiration Date: 02/28/2023
• Device Model Number: S1395108D
• Device Catalogue Number: S1395108D
• Device Lot Number: REFX4410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic