BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5426938 · Received February 10, 2016

    Report

    Report Number
    8040227-2015-00005
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    September 1, 2015
    Report Date
    May 4, 2020
    Manufacturer
    HINDUSTAN SYTINGES & 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

    Additional Manufacturer Narrative · 1

    FRAGMENTATION TESTING OF THE UNOLOK BLUNT FILL NEEDLE PER ISO (B)(4) 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 AND IS CONSIDERED THE SUBSTANTIAL EQUIVALENT. 25 SAMPLES OF EACH NEEDLE BRAND WERE TESTED. TEST RESULTS INDICATED THERE WAS NO CORING (FRAGMENTATION) OF THE RUBBER CLOSURE BY EITHER BRAND WHEN THE BLUNT FILL NEEDLE ARE TESTED PER ISO (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THREE (3) DIFFERENT USERS EXPERIENCED CORING WHEN USING THE UNOLOK (BLUNT FILL) NEEDLE. THE CUSTOMER HAD RECENTLY SWITCHED FROM ANOTHER BRAND AND DID NOT EXPERIENCE CORING WITH THE OTHER BRAND. THE CUSTOMER STATES THEY DID HOT CHANGE THEIR PROTOCOL WHEN IMPLEMENTING THE NEEDLE CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87025 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYTINGES & MEDICAL DEVICES LTD. (HMD) 17531D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown