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

Model Number	S1193108D2
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Single lumen picc [peripherally inserted central catheter] placed on [redacted], xray reports picc is in satisfactory position.Iv team receives a consult on [redacted], the next day, to assess picc due to not flushing or drawing.Xray re-did to confirm placement before giving cathflo.Xray reports picc tip is no longer in satisfactory position.Picc catheter changed out to new picc catheter; xray reports catheter tip is in satisfactory position.Iv team receives a consult on [redacted], the following day, to assess picc due to not flushing or drawing.Rn was concerned on assessment of picc site because there was induration and redness around the dressing site.Picc removed and found that it was kinked at the 4 cm mark.

• 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: 22319290
• Report Number: 22319290
• Device Sequence Number: 21063911
• Product Code: LJS
• UDI-Device Identifier: 00801741154874
• UDI-Public: (01)00801741154874
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2025
• Report Date (Section F): 06/11/2025

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: S1193108D2
• Device Catalogue Number: S1193108D2
• Device Lot Number: REKP1293
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Date Report Sent to FDA: 06/11/2025