BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5427295 · Received February 10, 2016

    Report

    Report Number
    8040227-2015-00001
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    June 26, 2015
    Report Date
    May 1, 2020
    Manufacturer
    HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD)
    Product Code
    FMI
    PMA / PMN Number
    K945225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT METAL DEBRIS WAS FOUND IN THE TIP OF THE NEEDLE. IT WAS ALSO REPORTED THIS CONDITION OCCURED FOUR (4) TIMES IN THE SAME WEEK. THIS DID NOT OCCUR DURING THE TREATMENT OF A PATIENT. NO SUSPECT DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87001 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD) 16561M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown