MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. INTRODUCER NEEDLE; INTRODUCER, CATHETER

Model Number	S03421-275
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During insertion of surelock safety introducer needle vascular access rn experienced difficulty puncturing skin.Noted there was no sign of hitting any tendon of muscle through ultrasound.Due to difficulty puncturing vein, had to thread needle in before puncturing skin and inserting guidewire.Rn was ultimately able to access target vein safely with no harm to patient.

• Brand Name: INTRODUCER NEEDLE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 15949791
• Report Number: 15949791
• Device Sequence Number: 15288996
• Product Code: DYB
• UDI-Device Identifier: 00801741041815
• UDI-Public: (01)00801741041815
• 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): 11/11/2022
• Report Date (Section F): 11/11/2022

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: S03421-275
• Device Catalogue Number: S03421-275
• Device Lot Number: REGB1014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 11/11/2022