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

Model Number	S1274108D5
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Hub on sensor attachment would not flush.Peripherally inserted central catheter (picc) flushed perfectly, no damage to picc or sensor, this was checked prior to accessing vessel.Double lumen picc, so inserter checked blood return using second lumen after picc placed, blood return assessed once sensor removed.

• 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: 17729215
• Report Number: 17729215
• Device Sequence Number: 6399800
• Product Code: LJS
• UDI-Device Identifier: 00801741155154
• UDI-Public: (01)00801741155154
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/16/2023
• Report Date (Section F): 08/16/2023

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: S1274108D5
• Device Catalogue Number: S1274108D5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 08/16/2023