MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	382612
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Rn in the process of placing iv.24 g iv removed from packaging, lid and catheter was not attached to needle.When iv was pulled out of packaging, the entire needle was out and exposed.Needle placed in sharps, new iv obtained.

• Brand Name: BD INSYTE AUTOGUARD
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 22210638
• Report Number: 22210638
• Device Sequence Number: 12948831
• Product Code: FOZ
• UDI-Device Identifier: 00382903826124
• UDI-Public: (01)00382903826124
• 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): 06/10/2025
• Report Date (Section F): 06/10/2025

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: 382612
• Device Catalogue Number: 382612
• Device Lot Number: 5037133
• 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: 06/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2025
• 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: 06/10/2025