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

Model Number 10161

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

Vaccine was successfully administered using a 1 ml vanishpoint syringe.When retracted, the needle came out the top of the syringe plunger at speed.The needle came to rest in the hand of the vaccinator.This presented a significant risk of needlestick injury.The patient has a noted infection of (b)(6).Fda safety report id # (b)(4).

• Brand Name: VANISHPOINT SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES INC; little elm TX 75068
• MDR Report Key: 11514659
• MDR Text Key: 241021116
• Report Number: MW5100073
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/12/2021

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
• Device Operator: Health Professional
• Device Model Number: 10161
• Device Catalogue Number: 10161
• Device Lot Number: G201004
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR