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

Model Number	S1385108D5
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While performing a peripherally inserted central catheter (picc) line placement, needle for lidocaine injection in the picc line kit was damaged and not functional (completely bent).Then when registered nurse (rn) deployed safety device for the 21 gauge access needle, the green piece came right off.Rn was able to use an alternative needle for lidocaine injection.Healthcare provider kept uncovered used dirty needle away from other equipment pieces on tray so as not to have an accidental needle stick.Healthcare provider kept non-functioning/damage pieces for analysis, notified bard representative, who placed an incident report with bard, and risk department notified.

• Brand Name: POWERPICC PROVENA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 21392084
• Report Number: 21392084
• Device Sequence Number: 8746576
• Product Code: LJS
• UDI-Device Identifier: 00801741155178
• UDI-Public: (01)00801741155178(17)251130(10)REJV1658
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2025
• Report Date (Section F): 02/09/2025

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: S1385108D5
• Device Catalogue Number: S1385108D5
• Device Lot Number: REJV1658
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Date Report Sent to FDA: 02/09/2025