MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD SAFETY GUIDE; SYRINGE, PISTON

Model Number	305935
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure- administration of insulin.When the insulin was drawn up, it was observed that the plunger was in 2 pieces, as evidenced by separation in the fluid.Not used on patient.

• Brand Name: BD SAFETY GUIDE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 19058691
• Report Number: 19058691
• Device Sequence Number: 15101362
• Product Code: FMF
• UDI-Device Identifier: 00382903059355
• UDI-Public: (01)00382903059355(17)3216615R1(10)20280831
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/15/2024
• Report Date (Section F): 03/15/2024

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: 305935
• Device Catalogue Number: 00382903059355
• Device Lot Number: 3216615R1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2024
• 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: 03/15/2024