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

Model Number	10161
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter stated needle was missing out of syringe after injection was administered to patient (reporter's husband).Reporter stated doctors are having a hard time locating the needle and the patient has to have surgery to remove needle.Patient is currently in pain and feeling uncomfortable.Patient can feel the needle in his left buttock.

• Brand Name: VANISHPOINT SYRINGE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.
• MDR Report Key: 10224249
• Report Number: MW5095347
• Device Sequence Number: 16929732
• Product Code: MEG
• UDI-Device Identifier: 00613703101600
• UDI-Public: 00613703101600
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 10161
• Device Catalogue Number: 10161
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Weight: 98