BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT

    MDR report key: 8273161 · Received January 24, 2019

    Report

    Report Number
    8273161
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    December 31, 2018
    Report Date
    January 7, 2019
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VANISHPOINT INSULIN SYRINGES FROM RETRACTABLE TECHNOLOGIES, INC. LOT # F180103 REF# 10211. REGISTERED NURSE WENT TO ADMINISTER SUBCUTANEOUS MEDICATION AND WHEN THE NEEDLE HIT THE SKIN IT BENT SIDEWAYS, NOT ABLE TO BE USED. A SECOND SYRINGE WAS THEN USED (SAME LOT) THIS TIME MEDICATION DELIVERED, BUT THE NEEDLE WOULD NOT RETRACT AFTER INJECTION EVEN THOUGH PLUNGER WAS PUSHED ALL THE WAY IN AS FAR AS IT WOULD GO. NO INJURIES. NO HARM TO PATIENT OR STAFF. MANUFACTURER RESPONSE FOR INSULIN SYRINGE, VANISHPOINT INSULIN SYRINGE (PER SITE REPORTER). NONE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68333 VANISHPOINT SYRINGE, ANTISTICK MEG RETRACTABLE TECHNOLOGIES, INC 10211 F180103

    Patients

    Seq Age Sex Outcome Treatment
    1