MAUDE Adverse Event Report: TERUMO (PHILIPPINES) CORPORATION SURGUARD3; NEEDLE HYPODERMIC, SINGLE LUMEN

Model Number SG3+1816

Device Problem Difficult to Open or Close (2921)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/16/2020

Event Type  malfunction  

Event Description

When the nurse was closing the safety device over injection needle, the device did not close all the way which resulted in a needle stick.Fda safety report id# (b)(4).

• Brand Name: SURGUARD3
• Type of Device: NEEDLE HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO (PHILIPPINES) CORPORATION
• MDR Report Key: 11372025
• MDR Text Key: 233469842
• Report Number: MW5099560
• Device Sequence Number: 1
• Product Code: FMI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SG3+1816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other