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

Model Number	10131
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse noted that 2 vanishpoint tb 1ml 27g 1/2" syringes were difficult to retract while giving im injections (immunizations) on 2 different occasions, when needle retracted and syringe pulled away from skin it actually grabbed the skin.Needles discarded - reported to the manufacturer on 10/2, they are sending a container to obtain same device from the same lot used by eh nurse.I will send to them as soon as i receive container for mailing.Manufacturer response for syringe, antistick, vanishpoint® (per site reporter) : they are sending a container for evaluation of a syringe/needle from the same lot used/defective.

• Brand Name: VANISHPOINT
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 9202319
• Report Number: 9202319
• Device Sequence Number: 16901867
• Product Code: MEG
• UDI-Device Identifier: 00613703101303
• UDI-Public: (01)00613703101303
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/02/2019
• Report Date (Section F): 10/02/2019

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: G180306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2019
• 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: 10/02/2019