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

Model Number	10131
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: nurse manager reports that one of the rns brought her the needle and stated it snapped when they were drawing up heparin.Rn did not get poked, and it was not used on the patient.

• Brand Name: VANISHPOINT®
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 22663464
• Report Number: 22663464
• Device Sequence Number: 3701862
• Product Code: MEG
• UDI-Device Identifier: 00613703101303
• UDI-Public: (01)00613703101303
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025
• Report Date (Section F): 07/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: 10131
• Device Catalogue Number: 10131
• Device Lot Number: G389A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• 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: 07/15/2025