BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5174717 · Received October 24, 2015

    Report

    Report Number
    8040409-2015-00004
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    August 25, 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
    NC, 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 SUSPECTED 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 A SUBSTANTIAL EQUIVALENT. TWENTY-FIVE 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 NEEDLES ARE TESTED PER ISO 7864.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A NURSE CORED A VIAL, SHE FOUND RUBBER FLOATING IN THE VIAL AFTERWORDS. THIS WAS REPORTED TO HAPPEN 2 TIMES ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705164 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. 02463 17531D

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR