BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5173718 · Received October 24, 2015

    Report

    Report Number
    8040409-2015-00005
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    September 1, 2015
    Report Date
    October 21, 2015
    Manufacturer
    HINDUSTAN SYRINGES & MEDICAL DEVICES LTD.
    Product Code
    FMI
    PMA / PMN Number
    K945225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FRAGMENTATION TESTING OF THE UNOLOK BLUNT FILL NEEDLE PER ISO 7864 WAS CONDUCTED BY THE FACTORY IN AN ATTEMPT TO RECREATE THE CORING FAILURE MODE OF THE SUSPECT BATCH WITH RETAIN SAMPLES FROM BATCH # 17531D, AND COMPETITOR BD SAMPLES (BATCH# 4242782). THE BD PRODUCT IS ALSO USED BY THE COMPLAINANT IN THEIR KIT, AND IS CONSIDERED A SUBSTANTIAL EQUIVALENT. TWENTY-FIVE SAMPLES OF EACH BRAND WERE TESTED UNDER THE SAME CONDITIONS. TEST RESULTS INDICATED THERE WAS NO CORING (FRAGMENTATION) OF THE RUBBER CLOSURE BY EITHER BRAND WHEN THE BLUNT FILL NEEDLES ARE TESTED PER ISO 7864.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THREE DIFFERENT USERS EXPERIENCED CORING WHEN USING THE UNOLOK NEEDLE. THE CUSTOMER HAD RECENTLY SWITCHED FROM ANOTHER BRAND AND DID NOT EXPERIENCE CORING WITH THE OTHER BRAND. THE CUSTOMER STATES THEY DID NOT CHANGE THEIR PROTOCOL WHEN IMPLEMENTING THE NEEDLE CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706059 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. 02463 17531D

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR