MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PROVENA MIDLINE CATHETER

Catalog Number	S4153108D
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When removing introducer needle from patient and engaging the safety, the green safety portion came apart from the needle.No injury to patient or staff.Nurse removed the remaining portion of the needle manually.

• Brand Name: PROVENA MIDLINE CATHETER
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 21834488
• Report Number: MW5168999
• Device Sequence Number: 15796235
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: 00801741153952
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/09/2025

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: 07/31/2026
• Device Catalogue Number: S4153108D
• Device Lot Number: REKP0118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White