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

Model Number	10311
Health Effect - Clinical Code	Underdose (2542)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Syringe with auto-retract needle malfunctioned during im administration for pt.Medication leaked from syringe, leaving staff unsure of how much of the medication pt actually received.

• Brand Name: VANISHPOINT
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; litle elm TX 75068
• MDR Report Key: 11384696
• Report Number: 11384696
• Device Sequence Number: 4567983
• 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): 02/11/2021
• Report Date (Section F): 02/11/2021

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: A942A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/11/2021