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

Model Number 16-SNT1C2705

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907); Protective Measures Problem (3015)

Patient Problems Needle Stick/Puncture (2462); Unspecified Tissue Injury (4559)

Event Date 12/17/2022

Event Type  malfunction  

Event 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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 1125 sycamore road; manteno IL 60950
• MDR Report Key: 16193959
• MDR Text Key: 307579003
• Report Number: 16193959
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10612479207322
• UDI-Public: 10612479207322
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 01/03/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1