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

Model Number	1174108D4
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Our vascular access team attempted to flush a "bard powerpicc" [peripherally inserted central catheter] that had been placed 24 hours earlier, with no luck.The rn was not able to flush the picc or have blood return once accessing the picc line.Patient had a right humerus x-ray, which showed the picc catheter double looped on itself at the patient's mid humerus.Patient underwent a picc underwire exchange in interventional radiology without issues, which fixed the double loop.

• Brand Name: POWERPICC
• 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: 22505813
• Report Number: 22505813
• Device Sequence Number: 8745927
• Product Code: LJS
• UDI-Device Identifier: 00801741155048
• UDI-Public: (01)00801741155048
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2025
• Report Date (Section F): 06/25/2025

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: 1174108D4
• Device Catalogue Number: 1174108D4
• Device Lot Number: REKP0108
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• 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: 85 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Date Report Sent to FDA: 06/25/2025