BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 14017486 · Received April 5, 2022

    Report

    Report Number
    3005798905-2022-03045
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    February 24, 2022
    Report Date
    April 5, 2022
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMF
    PMA / PMN Number
    K130212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS AND PRODUCTION RECORDS ANALYZED FOR LOT 52385 WAS CONDUCTED. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    MHC RECEIVED A MEDICAL DEVICE REPORT (MW5108011) FROM THE FDA ON (B)(6) 2022 AS FOLLOWS: FOUR VACCINES WERE GIVEN TO A NEW EMPLOYEE. SAFETY REPORT ACTIVATED ON ALL NEEDLES AFTER EACH INJECTION. WHEN PICKING UP SYRINGE USED TO GIVE TDAP (EASY TOUCH FLIPLOCK SAFETY SYRINGE - MHC MEDICAL PRODUCTS) TO PLACE IN THE SHARPS CONTAINER, FELT A STICK IN LEFT PALM AND SAW ONE DROP OF BLOOD. LOOKED AT SYRINGE AND NOTED THE NEEDLE WAS NOT ALIGNED WITH THE SAFETY DEVICE. IT WAS MAKING A "CLICK" SOUND EVEN WHEN IT WAS NOT CORRECTLY IN THE SAFETY FEATURE. IT WAS PASSING TO THE RIGHT OF THE SAFETY DEVICE WHILE TRYING TO ACTIVATE THE SAFETY FEATURE ON THE NEEDLE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049996 EASYTOUCH FLIP LOCK SAFETY SYRINGE FMF MHC MEDICAL PRODUCTS, LLC 52385

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other