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

Model Number	10131
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During medication injection, the device failed and heparin shot back into the rn's eyes.She had to use the eye wash station to get the medication out.

• Brand Name: VANISHPOINT®
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 8284853
• Report Number: 8284853
• Device Sequence Number: 11152221
• Product Code: MEG
• UDI-Device Identifier: 00613703101303
• UDI-Public: (01)00613703101303
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/17/2018
• Report Date (Section F): 12/17/2018

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: Health Professional
• Device Model Number: 10131
• Device Catalogue Number: 10131
• Device Lot Number: G180711
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2019
• 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: 12/17/2018