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

Model Number	10131
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Rn was restocking the 1ml vanishpoint ii syringe packages for the med room.The syringes are stocked on the supply cart as strips of approximately 10.Rn was separating the packages so they would be individually restocked in the supply cupboard and was stuck by a needle on her left index finger.Upon close inspection of the syringe packages, as all of them appeared unopened, it was noted that a needle in one syringe package was not protected by the cap, protruding out of the packaging.

• Brand Name: VANISHPOINT®
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 25407519
• Report Number: 25407519
• Device Sequence Number: 18825544
• 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): 06/02/2026
• Report Date (Section F): 06/02/2026

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: G406A
• 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: 06/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/02/2026