MAUDE Adverse Event Report: BECTON, DICKINSON, AND COMPANY BD PET SYRINGES, 0.5ML X 12MM, U-100; SYRINGE, PISTON

Model Number	323003
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was brought to my attention, on a number of occasions, when an insulin syringe was inserted into the insulin, it failed to draw the insulin from the vial, just air.

• Brand Name: BD PET SYRINGES, 0.5ML X 12MM, U-100
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON, AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7619144
• Report Number: 7619144
• Device Sequence Number: 16499329
• Product Code: FMF
• UDI-Device Identifier: 00382903230020
• UDI-Public: (01)00382903230020
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2018
• Report Date (Section F): 06/14/2018

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: Nurse
• Device Model Number: 323003
• Device Catalogue Number: 323003
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/14/2018