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

Model Number	10311
Health Effect - Clinical Code	Underdose (2542)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
This is the third event in which the vanish point retractable syringe has malfunctioned and patient did not receive all the meds.

• Brand Name: VANISHPOINT
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 10927256
• Report Number: 10927256
• Device Sequence Number: 16766539
• 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): 11/09/2020
• Report Date (Section F): 11/09/2020

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: A93BA
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2020
• 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: 11/09/2020