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

Model Number	15271
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The plunger inside the syringe that is used to accurately measure the number of units to be administered has been slanted.Since one side is higher than the other there is no way to determine an accurate dose to administer.

• Brand Name: VANISHPOINT®
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 7432495
• Report Number: 7432495
• Device Sequence Number: 193769
• Product Code: MEG
• UDI-Device Identifier: 00613703152701
• UDI-Public: (01)00613703152701
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2018
• Report Date (Section F): 03/29/2018

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: Nurse
• Device Expiration Date: 03/28/2022
• Device Model Number: 15271
• Device Catalogue Number: 15271
• Device Lot Number: M170406
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2018
• 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: 03/29/2018