MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD LUER-LOK; SYRINGE, PISTON

Model Number	305060
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
3ml syringe was used to draw up iv medication.Upon wasting the medication, registered nurse (rn) noticed the syringe did not have any volume markings.

• Brand Name: BD LUER-LOK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 19836777
• Report Number: 19836777
• Device Sequence Number: 17804289
• Product Code: FMF
• UDI-Device Identifier: 00382903050604
• UDI-Public: (01)00382903050604
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/22/2024
• Report Date (Section F): 05/22/2024

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
• Device Model Number: 305060
• Device Catalogue Number: 305060
• Device Lot Number: 4025439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2024
• 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: 05/22/2024