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

Model Number	S1295108FD2
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During insertion of double lumen picc there was no ecg reading from the wire in the picc to the ultrasound machine.All connections were checked.The wire inside the picc was removed.There were two places from the tip extending 3 inches that appeared bent.The piece closest to the tip of the wire broke off onto the sterile field.

• Brand Name: POWERPICC PROVENA SOLO
• 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: 20597954
• Report Number: 20597954
• Device Sequence Number: 6550823
• Product Code: LJS
• UDI-Device Identifier: 00801741154904
• UDI-Public: 00801741154904
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/05/2024
• Report Date (Section F): 08/05/2024

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 Model Number: S1295108FD2
• Device Catalogue Number: S1295108FD2
• Device Lot Number: REJN3811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Date Report Sent to FDA: 08/05/2024