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

Model Number	AC1182252
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Safety issue with guidewire iv catheter used to place peripheral us [ultrasound] ivs.While inserting the iv in the patient, the needle retracting mechanism would not engage.The catheter also did not occlude as it should, causing rn to have to hold pressure while removing the needle from the patient's arm which increased the risk of needlestick.Thankfully, another rn nearby was able to safely remove and discard the sharp.

• 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: 23778080
• Report Number: 23778080
• Device Sequence Number: 18671343
• Product Code: FOZ
• UDI-Device Identifier: 00801741138003
• UDI-Public: (01)00801741138003
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 12/01/2025
• Report Date (Section F): 12/01/2025

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 Model Number: AC1182252
• Device Catalogue Number: AC1182252
• Device Lot Number: REKT3046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/01/2025