FDA Adverse Event Malfunction Summary report: N

VANISHPOINT

MDR report key: 12180148 · Received July 16, 2021

Report

Report Number
12180148
Event Type
Malfunction
Date Received
July 16, 2021
Date of Event
June 21, 2021
Report Date
July 12, 2021
Manufacturer
RETRACTABLE TECHNOLOGIES, INC.
Product Code
MEG
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CT
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

A NURSE ON EP 8-8 FOUND AN INSULIN SYRINGE THAT IS NOT DRAWING UP INSULIN. I HAVE THE SYRINGE AND LOT NUMBER (BELOW). WE TESTED MULTIPLE OTHER SYRINGES FROM THAT LOT, AND THEY WERE FUNCTIONAL. LOT# M210101.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1080328 VANISHPOINT SYRINGE, ANTISTICK MEG RETRACTABLE TECHNOLOGIES, INC. 15271 M210101

Patients

Seq Age Sex Outcome Treatment
1