BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5223843 · Received November 15, 2015

    Report

    Report Number
    8040227-2015-00007
    Event Type
    Malfunction
    Date Received
    November 15, 2015
    Date of Event
    October 15, 2015
    Report Date
    May 19, 2016
    Manufacturer
    HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD)
    Product Code
    FMI
    PMA / PMN Number
    K945225
    Removal / Correction Number
    Z-0444-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    FRAGMENTATION TESTING OF THE UNOLOK BLUNT FILL NEEDLE PER ISO 7864 WAS CONDUCTED BY THE MANUFACTURER IN AN ATTEMPT TO RECREATE THE CORING FAILURE MODE OF THE DEVICE AND COMPARE THE DEVICE'S PERFORMANCE UNDER THIS TEST PROTOCOL TO A MARKET COMPETITOR. INITIAL 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. AS THE COMPANY CONTINUED TO RECEIVE COMPLAINTS ACROSS MULTIPLE LOT NUMBERS FOR THIS ISSUE, A LARGER STUDY WAS INITIATED WITH TWO COMPETITIVE BRANDS WHICH INCORPORATED TEST VIALS SOURCED FROM THE US MARKET TO BETTER SIMULATE THE CONDITIONS REPORTED FROM THE FIELD. THIS LARGER TEST INCORPORATED MULTIPLE PUNCTURES WITH THE SAME NEEDLE TO SIMULATE STANDARD PRACTICE IN MANY OF THE HOSPITALS THAT ISSUED THE COMPLAINTS, FOLLOWING THEIR INTERNAL PROTOCOLS. IN MOST CASES THE NUMBER OF MULTIPLE PUNCTURES DOES NOT EXCEED FOUR (4) WITH THE SAME NEEDLE, WITH ONE (1) PUNCTURE PER NEEDLE BEING THE NORM. A COPY OF THIS REPORT IS ATTACHED ALSO. AT THIS TIME THE MANUFACTURER IS INVESTIGATING A ROOT CAUSE. ALTHOUGH THE OCCURRENCE IS LOW, AND WE HAVE RECEIVED A RELATIVELY LOW NUMBER OF COMPLAINTS, THE MANUFACTURER HAS INITIATED A VOLUNTARY RECALL OF THE PRODUCT IN THE US MARKET, AND HAS HALTED PRODUCTION AND DISTRIBUTION UNTIL A ROOT CAUSE AND CORRECTIVE ACTION CAN BE IDENTIFIED. THE MANUFACTURER THROUGH ITS US AGENT, AND THE INITIAL IMPORTER, (B)(4)., ARE CURRENTLY WORKING WITH THE FDA TO RECALL ALL SEVEN (7) LOTS DISTRIBUTED TO THE US MARKET SINCE 2014. THOSE BATCHES HAVE BEEN IDENTIFIED AS: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D, AND 25551M.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ACCESSING THE ANGIOMAX VIAL USING THE BLUNT TIP NEEDLE, A PIECE OF RUBBER STOPPER WAS DISCOVERED IN THE SOLUTION. THE NURSE PREPARING THE SOLUTION NOTICED THAT THE RUBBER HAD DISLODGED AND WAS PUSHED INTO THE VIAL BEFORE THE MEDICATION WAS ADMINISTERED TO A PATIENT. NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754812 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD) 17531D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown