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

Lot Number	REHU189B
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse attempted to place a peripherally inserted central catheter line in the patient's left upper extremity.When trying to advance the peripherally inserted central catheter to the superior vena cava, the peripherally inserted central catheter coiled.The nurse was not able to retract the peripherally inserted central catheter line.An x-ray of the left upper extremity showed the peripherally inserted central catheter line was knotted.The patient was taken to the operation room for peripherally inserted central catheter line removal.

• Brand Name: POWERPICC HF CATHER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 18797669
• Report Number: MW5152048
• Device Sequence Number: 7231658
• Product Code: LJS
• UDI-Device Identifier: 00801741038020
• UDI-Public: (01)00801741038020
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: REHU189B
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American