BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHIFENG SYRINGES AND NEEDLES FOR IMMUNIZATIONS

    MDR report key: 16312909 · Received February 6, 2023

    Report

    Report Number
    MW5114743
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Report Date
    February 2, 2023
    Manufacturer
    CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM (B)(6) 2022- (B)(6)2022, WE HAD 12 (TWELVE) NEEDLESTICK INCIDENTS WHERE MEDICAL PROFESSIONAL USED THE SHIFENG NEEDLES TO PROVIDE IMMUNIZATIONS AND THE DEVICE WAS REPORTED BY THE HEALTHCARE PROFESSIONALS TO BE FAULTY. EXAMPLES WERE " THE SAFETY COVER AND THE NEEDLE DID NOT ALIGN PROPERLY", OR THE "NEEDLE POPPED OFF OF THE SYRINGE WHEN ATTEMPTING TO COVER", OR "THE SAFETY SHIELD WOULD NOT LOCK PROPERLY". LOT NUMBERS INCLUDE THE FOLLOWING 210307, 3070060, 210207, 210102).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116819 SHIFENG SYRINGES AND NEEDLES FOR IMMUNIZATIONS NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD. 210307
    116820 SHIFENG SYRINGES AND NEEDLES FOR IMMUNIZATIONS NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD. 3070060
    116821 SHIFENG SYRINGES AND NEEDLES FOR IMMUNIZATIONS NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD. 210207
    116822 SHIFENG SYRINGES AND NEEDLES FOR IMMUNIZATIONS NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD. 210102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SYRINGE.