MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. ACCUCATH ACE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	AC1182250
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Accucath ace 18g, we've had multiple issues with multiple patients.We had one catheter that auto reacted during procedure without the auto retractor button being hit.Another was the guidewire had straightened out within the catheter and was catching and could not be advanced.Another two were the catheter was successfully placed but the auto retract on that would not retreat on it's own and the needle and had to be withdrawn with the needle still exposed.These are all from the same lot, we have since pulled the remainder of the stock from the lot from our department.Lot number rekp0794 it's the accucath ace 2 1/4 inch catheters.Multiple patients yesterday and today.

• Brand Name: ACCUCATH ACE
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 22352602
• Report Number: 22352602
• Device Sequence Number: 20853636
• Product Code: FOZ
• UDI-Device Identifier: 00801741137945
• UDI-Public: (01)00801741137945
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/25/2025
• Report Date (Section F): 06/25/2025

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
• Device Model Number: AC1182250
• Device Catalogue Number: AC1182250
• Device Lot Number: REKP0794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• 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: Unknown
• Date Report Sent to FDA: 06/25/2025