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

Model Number	CK000189D
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During set up for picc insertion kit missing 2 chg applicators for skin prep.Additional chg applicators added to prep field and applied per policy.Picc successfully placed.

• 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: 19546552
• Report Number: 19546552
• Device Sequence Number: 6716174
• Product Code: LJS
• UDI-Device Identifier: 00801741148286
• UDI-Public: (01)00801741148286
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/14/2024
• Report Date (Section F): 02/26/2024

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: CK000189D
• Device Catalogue Number: CK000189D
• Device Lot Number: REHV26007
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Date Report Sent to FDA: 02/26/2024