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

Model Number	10131
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This rn was providing an ordered subcutaneous medication with the standard safety needle per hospital protocol, the needle was not safe, it did not retract as it should have once the injection was administered, it continued to stay straight out almost causing this rn to end up with a needle stick.Tuberculin needle- vanish point ii syringe ref number 10131- lot g388a.

• Brand Name: VANISHPOINT®
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 22713917
• Report Number: 22713917
• Device Sequence Number: 9583423
• Product Code: MEG
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/28/2025
• Report Date (Section F): 07/28/2025

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
• Device Model Number: 10131
• Device Catalogue Number: 10131
• Device Lot Number: G388A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/28/2025