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

Model Number	1174108D5
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Unable to advance peripherally inserted central catheter (picc) line wire during insertion into right upper arm.Noted the needle was "solid" at the end.

• 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: 18475873
• Report Number: 18475873
• Device Sequence Number: 6895586
• Product Code: LJS
• UDI-Device Identifier: 00801741155147
• UDI-Public: (01)00801741155147
• 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): 11/08/2023
• Report Date (Section F): 11/08/2023

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: 1174108D5
• Device Catalogue Number: 1174108D5
• Device Lot Number: REHU1173
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2024
• 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 Sex: Male
• Patient Weight: 45 KG
• Patient Race: White
• Date Report Sent to FDA: 11/08/2023