MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SAFETY-LOK; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	305900
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
While preparing the or for a surgical procedure, the scrub tech found a bd safetyglide 22g x 1 1/2 hypodermic needle in its packaging with no protective cover on the sharp end which was also protruding out the plastic packaging.The scrub tech was able to prevent the device from reaching the surgical table and also from stabbing herself during the process.

• Brand Name: BD SAFETY-LOK
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10413040
• Report Number: 10413040
• Device Sequence Number: 14340585
• Product Code: FMI
• UDI-Device Identifier: 00382903059003
• UDI-Public: (01)00382903059003
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/07/2020
• Report Date (Section F): 08/07/2020

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: No Information
• Device Model Number: 305900
• Device Catalogue Number: 305900
• Device Lot Number: 9316337
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2020
• 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: 08/07/2020