MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT SYRINGE; SYRINGE, ANTISTICK

Lot Number A909A

Device Problems Failure to Deliver (2338); Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2021

Event Type  malfunction  

Event Description

Staff was attempting to administer medication and plunger would not advance to administer medication.Fda safety report id# (b)(4).

• Brand Name: VANISHPOINT SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.
• MDR Report Key: 12160918
• MDR Text Key: 261661503
• Report Number: MW5102499
• Device Sequence Number: 1
• Product Code: MEG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: A909A
• 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 Age: 27 YR