MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. MCKESSON SYRINGE/NDL,TB, 1CC; SYRINGE, PISTON

Model Number	16-SNT1C2705
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Unspecified Tissue Injury (4559)
Date of Event	12/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The needles for lidocaine- i had one break off in today and spray us both in the process.I¿ve had this happen in the past with the same needles.The needle just slips on it is not a luer lock.This causes issues with the needle coming off upon removal from the skin and stick injuries.

• Brand Name: MCKESSON SYRINGE/NDL,TB, 1CC
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 1125 sycamore road; manteno IL 60950
• MDR Report Key: 16193959
• Report Number: 16193959
• Device Sequence Number: 11805540
• Product Code: FMF
• UDI-Device Identifier: 10612479207322
• UDI-Public: 10612479207322
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/03/2023
• Report Date (Section F): 01/03/2023

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: 16-SNT1C2705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2023
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/03/2023