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

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2021

Event Type  malfunction  

Event Description

Syringe use for covid-19 under emergency use authorization (eua): vanish point syringe was used to draw up the covid vaccine for administration at a clinic.The needle punctured the cap after recapping after it was drawn up.Proper recapping techniques were followed during this process.Fda safety report id # (b)(4).

• Brand Name: VANISHPOINT SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES INC.
• MDR Report Key: 11796719
• MDR Text Key: 249959887
• Report Number: MW5101241
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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