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	11/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Rn administered bedtime dose of lantus to patient.Rn attempted to retract needle from insulin syringe per best practice and removed syringe from pt's abdomen.Rn noted that syringe did not retract.Rn and patient both safe and needle did not stick anyone.Rn attempted to retract needle once syringe removed from patient's abdomen, however the needle still would not retract.Packaging from needle saved.

• Brand Name: VANISHPOINT®
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 8114953
• Report Number: 8114953
• Device Sequence Number: 1579896
• 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): 11/09/2018
• Report Date (Section F): 11/09/2018

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
• Device Lot Number: M171206
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2018
• 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: 11/09/2018