BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5099344 · Received September 24, 2015

    Report

    Report Number
    8040409-2015-00003
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 24, 2015
    Report Date
    September 23, 2015
    Manufacturer
    HINDUSTAN SYRINGES & MEDICAL DEVICES LTD.
    Product Code
    FMI
    PMA / PMN Number
    K945225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 AND IS CONSIDERED THE SUBSTANTIALLY 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 7864. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE CAUSED CORING OF THE MEDICATION TOP WHICH WAS DRAWN UP INTO THE SYRINGE. NURSE DREW DIPRIVAN (PROPOFOL) FROM A GLASS VIAL USING A BLUNT NEEDLE. WHEN MEDICATION WAS DRAWN INTO THE SYRINGE, THE NURSE NOTED A SMALL PIECE OF RUBBER (CORE OR CORING) INSIDE THE SYRINGE. THE MEDICATION WAS NOT ADMINISTERED. NONE OF THE NEEDLES WERE SAVED FOR EVALUATION. THE MANUFACTURER ATTEMPTED TO RECREATE THE CORING CONDITION USING RETAIN SAMPLES AND SIMILAR MEDICATION VIALS BUT WAS NOT ABLE TO RECREATE THE CORING CONDITION WHEN USING THE DEVICE AS THE INSTRUCTIONS SPECIFY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633388 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. 02463 17531D

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR