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

Model Number	305932
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: after i administered subcutaneous insulin and removed the needle from the patient's skin, i went to engage the safety device for the needle.The white safety device for the insulin needle slipped, which caused my right hand to move forward, further causing the needle to puncture the inner part of my left index finger.I tried to activate the safety device, but the device slipped, which the safety device was faulty.Needlestick occurred.Please note the device information provided is from a "like" device as the device involved has been discarded by staff.

• Brand Name: SAFETYGLIDE INSULIN SYRINGE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr.; franklin lakes NJ 07417
• MDR Report Key: 22282724
• Report Number: 22282724
• Device Sequence Number: 18373210
• Product Code: MEG
• UDI-Device Identifier: 00382903059324
• UDI-Public: (01)00382903059324
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 06/12/2025
• Report Date (Section F): 06/12/2025

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
• Operator of Device: Health Professional
• Device Model Number: 305932
• Device Catalogue Number: 305932
• Device Lot Number: 4254095K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/12/2025