MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWERPICC PROVENA DOUBLE LUMEN 4F; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	S1294108D1
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A powerpicc provena, polyurethane picc catheter with solo valve technology was inserted on (b)(6) 2021 using lot number refw0154.Three (3) linear radiopaque foreign bodies are seen, one in the svc/atrium, one in the posterior right liver and one in the right lower lobe.These appear to represent wire fragments.Fda safety report id# (b)(4).

• Brand Name: BARD POWERPICC PROVENA DOUBLE LUMEN 4F
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 13152031
• Report Number: MW5106431
• Device Sequence Number: 4666731
• Product Code: LJS
• UDI-Device Identifier: 00801741154799
• UDI-Public: (01)00801741154799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/30/2021

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 Expiration Date: 11/30/2022
• Device Model Number: S1294108D1
• Device Catalogue Number: S1294108D1
• Device Lot Number: REFW0154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2022
• 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: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic