BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPOINT

    MDR report key: 19191230 · Received April 26, 2024

    Report

    Report Number
    19191230
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 3, 2024
    Report Date
    April 4, 2024
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN THE PAST ALMOST 2 YEARS, OUR FACILITY HAS HAD A TREMENDOUS NUMBER OF ISSUES WITH EASYPOINT NEEDLES. THEY ARE UNSAFE FOR MEDICAL PROFESSIONALS AND PATIENTS. ISSUES THAT WE HAVE HAD: NEEDLE NOT RETRACTING, BLOOD SPRAY WITH RETRACTION OF NEEDLE, NEEDLE POPPING OFF SYRINGE WITH ATTEMPTED RETRACTION WITH SYRINGE POPPING OUT, DULL NEEDLES, FAILING TO PUNCTURE SKIN, CAUSING PAIN, NEEDLES BENDING WHEN DRAWING UP MEDS, ABNORMAL CURVATURE OF TIP OF NEEDLE, SYRINGE/NEEDLE COMPLETELY FALLING APART UPON RETRACTION, PROTECTIVE CAP FALLING OFF WHEN REMOVED FROM PACKAGE, NEEDLES HAVING CONNECTION ISSUES, NOT TIGHTENING, LEAKING AT THE HUB. WE HAVE GONE THROUGH THE PROPER CHANNELS, HAD RETRACTABLE TECHNOLOGY, INC (RTI) EDUCATORS OUT TO MEET WITH STAFF, SENT BACK DEFECTIVE NEEDLES, AND STILL NO RESOLUTION. OUR SUPPLY CHAIN DEPARTMENT HAS OVER 55 REPORTS, AND THIS DOESN'T ACCOUNT FOR THE EVENTS THAT OCCUR THAT ARE NOT REPORTED.

    Description of Event or Problem · 0

    IN THE PAST ALMOST 2 YEARS, OUR FACILITY HAS HAD A TREMENDOUS NUMBER OF ISSUES WITH EASYPOINT NEEDLES. THEY ARE UNSAFE FOR MEDICAL PROFESSIONALS AND PATIENTS. ISSUES THAT WE HAVE HAD: - NEEDLE NOT RETRACTING - BLOOD SPRAY WITH RETRACTION OF NEEDLE - NEEDLE POPPING OFF SYRINGE WITH ATTEMPTED RETRACTION WITH SYRINGE POPPING OUT - DULL NEEDLES, FAILING TO PUNCTURE SKIN, CAUSING PAIN - NEEDLES BENDING WHEN DRAWING UP MEDS - ABNORMAL CURVATURE OF TIP OF NEEDLE - SYRINGE/NEEDLE COMPLETELY FALLING APART UPON RETRACTION - PROTECTIVE CAP FALLING OFF WHEN REMOVED FROM PACKAGE - NEEDLES HAVING CONNECTION ISSUES, NOT TIGHTENING - LEAKING AT THE HUB WE HAVE GONE THROUGH THE PROPER CHANNELS, HAD RETRACTABLE TECHNOLOGY, INC (RTI) EDUCATORS OUT TO MEET WITH STAFF, SENT BACK DEFECTIVE NEEDLES, AND STILL NO RESOLUTION. OUR SUPPLY CHAIN DEPARTMENT HAS OVER 55 REPORTS, AND THIS DOESN'T ACCOUNT FOR THE EVENTS THAT OCCUR THAT ARE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123309 EASYPOINT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI RETRACTABLE TECHNOLOGIES, INC. 82011 K201207
    435404 EASYPOINT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI RETRACTABLE TECHNOLOGIES, INC. 82011 K201207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown