BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25G X1 EASY POINT NEEDLE

    MDR report key: 10407229 · Received August 13, 2020

    Report

    Report Number
    MW5096068
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    July 14, 2020
    Report Date
    August 11, 2020
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    FMI
    UDI-DI
    00613703820129
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TUESDAY JULY 14TH AT APPROXIMATELY 3:00PM AN RN FROM THE (B)(6) CLINIC FROM (B)(6) HEALTH MEDICAL SERVICES WAS ADMINISTERING A VACCINE TO A PATIENT. AFTER PERFORMING THE INTRAMUSCULAR INJECTION THE RN ATTEMPTED TO ENGAGE THE INNATE SAFETY MECHANISM TO SHEATH THE NEEDLE. AFTER APPLYING PRESSURE THE RN'S HAND SLIPPED AND LACERATED THEIR LEFT UPPER THIGH. THE RN IMMEDIATELY WASHED THE AFFECTED AREA AND PLACED A BAND-AID ON THE WOUND. THE RN IMMEDIATELY NOTIFIED THE INFECTION CONTROL NURSE AND THE DIRECTOR OF NURSING. THE NURSE VISITED (B)(6) HEALTH FOR MEDICAL TREATMENT. THEIR PPE CONSISTED OF A SURGICAL MASK, GLOVES AND FACE SHIELD. EH&S IS INVESTIGATING THE 25G X1" EASYPOINT NEEDLE'S FAILURE TO NOTIFY THE MANUFACTURER OF THE MALFUNCTIONING DEVICE. THE LOT NUMBER IS K128A. EXPIRATION: 4/28/2024, MANUFACTURER EASYPOINT. REPORTING ON BEHALF OF INJURED NURSE FROM (B)(6) UNIVERSITY (B)(6) MEDICAL CENTER OCCUPATIONAL SERVICES WHO INJURED THEMSELVES ATTEMPTING TO ENGAGE ENGINEERED SHARP AFTER PERFORMING INVESTIGATION. PHI REGARDING TESTING WAS NOT PROVIDED ALTHOUGH PERSONNEL POTENTIALLY EXPOSED TO BBP ARE OFFERED POST EXPOSURE PROPHYLAXIS AND UNDERGO BASELINE SEROLOGY AS PART OF (B)(6) MEDICAL SURVEILLANCE. THE ER MOST LIKELY FOLLOWS THE SAME PROCEDURES. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869857 25G X1 EASY POINT NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI RETRACTABLE TECHNOLOGIES, INC. K128A 00613703820129

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization