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

Lot Number	G332A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Before withdrawing the medication in the syringe, this author retracted the plunger.Before inserting needle into medication vial to withdraw medication, this user noted that the spring collapsed in the barrel and did not advance appropriately when author attempted to advance the plunger upward/forward.Syringe was not utilized for patient use.

• Brand Name: VANISHPOINT
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; little elm TX 75068 0009
• MDR Report Key: 16573837
• Report Number: MW5115840
• Device Sequence Number: 5895665
• Product Code: MEG
• UDI-Device Identifier: 00613703101617
• UDI-Public: (01)00613703101617(10)G332A(11)2
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/15/2023

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 Lot Number: G332A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown