BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE (SYRINGE 1ML / NDL 27G 0.5IN SAFETY

    MDR report key: 15121665 · Received July 27, 2022

    Report

    Report Number
    MW5111161
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    January 1, 2022
    Report Date
    July 25, 2022
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRODUCT ISSUE DETAILS JANUARY - MARCH 2022 VANISHPOINT SYRINGES HAVE BEEN QUARANTINED FROM LOT G210701 VACCINES ADMINISTERED: 230 VACCINES. WASTED: 14 DAILY VACCINATOR SURVEY QUESTIONS NOTE: TOTAL OF FOUR (4) RN VACCINATORS PROVIDED FEEDBACK VIA THE STUDY. WHY DO YOU LIKE THIS NEEDLE? RETRACTABLE; QUICK AND SAFE FOR USER WHEN IT WORKS. WHY DON'T YOU LIKE THIS NEEDLE? GAVE VACCINE. NEEDLE DID NOT RETRACT WHEN VACCINE ADMINISTERED, PULLED SYRINGE OUT OF PT'S ARM. HAD TO DISCARD IN RED BIN. CONTINUED TO PUSH PLUNGER ON SYRINGE UNTIL IT FINALLY RETRACTED. VACCINATED PT. NEEDLE DID NOT RETRACT WHEN VACCINE ADMINISTERED. REMOVED SYRINGE FROM PATIENT'S ARM AND HAD TO APPLY ADDITIONAL FORCE BEFORE NEEDLE RETRACTED IN SYRINGE. HAVE YOU HAD ANY TROUBLE WITH UTILIZING THIS NEEDLE. SAME RESPONSES AS QUESTION #2. WOULD YOU PREFER TO UTILIZE THE NEEDLE WITH THE SAFETY CAP? PREFER SAFETY CAP OR ANOTHER RETRACTABLE SYRINGE. PATIENTS WERE INVOLVED BUT IDENTIFIERS WERE NOT COLLECTED. PATIENT SAFETY CONCERNS NOTED. SYMPTOMS: VANISH POINT SYRINGE / NEEDLE NOT RETRACTING SUSPECTED LOT: G210701 QUARANTINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317004 SYRINGE (SYRINGE 1ML / NDL 27G 0.5IN SAFETY SYRINGE, ANTISTICK MEG RETRACTABLE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention