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

Model Number	CK000187B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While placing a picc line, single lumen.Peel away sheath introducer that should be easily peeled away, the wings would not snap off.

• 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: 13948895
• Report Number: 13948895
• Device Sequence Number: 4792660
• Product Code: LJS
• UDI-Device Identifier: 00801741101847
• UDI-Public: (01)00801741101847
• 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): 03/15/2022
• Report Date (Section F): 03/15/2022

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: CK000187B
• Device Catalogue Number: CK000187B
• Device Lot Number: 210BA746
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2022
• 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: Female
• Patient Weight: 58 KG
• Date Report Sent to FDA: 03/15/2022