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

Model Number	305945
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
When the safety was engaged on the bd safetyglide 1ml syringe, the safety flew off and didn't cap needle.Very big potential for needle stick.

• Brand Name: SAFETYGLIDE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10183668
• Report Number: 10183668
• Device Sequence Number: 909219
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: (01)00382903059454
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 05/21/2020
• Report Date (Section F): 05/26/2020

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: 305945
• Device Catalogue Number: 305945
• Device Lot Number: 9269165J
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2020
• 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: 05/26/2020