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

Model Number	15271
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Rn drew up 2 units of humalog to administer for a blood sugar of 158.Second rn verified dose.Insulin administered with vanishpoint insulin syringe.When rn pressed plunger to end, needle would not retract.Once needle was removed from patient, the needle still would not retract.Rn unsure if patient received full 2 units.Physician was notified and instructed rn to not give another dose.Will recheck sugar at dinner.Patient aware to report signs and symptoms of hyperglycemia.

• Brand Name: VANISHPOINT®
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 7742125
• Report Number: 7742125
• Device Sequence Number: 1404744
• Product Code: FMF
• UDI-Device Identifier: 00613703152701
• UDI-Public: (01)00613703152701
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 07/25/2018
• Report Date (Section F): 07/25/2018

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: 15271
• Device Catalogue Number: 15271
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2018
• 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: 07/25/2018