MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SAFETYGLIDE; SYRINGE, ANTISTICK

Model Number	328446
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Administered lantus to patient.Went to slide safety on needle and stuck rn index finger.This has been the second needle stick with these insulin syringes.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12438176
• Report Number: 12438176
• Device Sequence Number: 17328230
• Product Code: MEG
• UDI-Device Identifier: 00382903284467
• UDI-Public: (01)00382903284467
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/24/2021
• Report Date (Section F): 09/02/2021

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: No Information
• Device Model Number: 328446
• Device Catalogue Number: 328446
• Device Lot Number: 1026135F
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 09/02/2021