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

Model Number	15271
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
When attempting to administer sliding scale insulin in a vanish point 0.5ml syringe, this rn noticed plunger was not level.Insulin discarded and new syringe obtained.Syringe inspected, plunger level, insulin administered.

• Brand Name: VANISHPOINT®
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln.; little elm TX 75068
• MDR Report Key: 7006095
• Report Number: 7006095
• Device Sequence Number: 19076906
• 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): 10/18/2017
• Report Date (Section F): 10/18/2017

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: No Information
• Device Model Number: 15271
• Device Catalogue Number: 15271
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2017
• 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: 10/18/2017