BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5412575 · Received February 5, 2016

    Report

    Report Number
    8040227-2015-00002
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Date of Event
    August 21, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO (2) NEEDLE HUBS BROKE DRING A PROCEDURE. THE NEEDLE HUMB BROKE AT THE BASE OF THE CANNULA. IT WAS ALSO REPORTED THAT THE BREAKING OCCURED MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72581 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD) 17531D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown