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

Model Number	10311
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse went to inject medication.She pushed in the plunger, but the rubber part did not engage, and medication did not go into the patient.Also, the sharps protection did not engage.

• Brand Name: VANISHPOINT
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 16609856
• Report Number: 16609856
• Device Sequence Number: 4777616
• Product Code: MEG
• UDI-Device Identifier: 00613703103109
• UDI-Public: (01)00613703103109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/21/2023
• Report Date (Section F): 03/21/2023

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: 10311
• Device Catalogue Number: 10311
• Device Lot Number: A936A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/21/2023