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

Model Number	AC1202250
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Upon ending the procedure there was a failed attempt to retract the wire.The needle would not also not retract although could be pushed manually back into housing.The wire was looping out of housing when needle was pushed back.

• 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: 24114610
• Report Number: 24114610
• Device Sequence Number: 9689286
• Product Code: FOZ
• UDI-Device Identifier: 00801741137952
• UDI-Public: (01)00801741137952
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/29/2025
• Report Date (Section F): 12/29/2025

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: AC1202250
• Device Catalogue Number: AC1202250
• Device Lot Number: REKS1271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2026
• 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
• Date Report Sent to FDA: 12/29/2025