BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5349062 · Received January 6, 2016

    Report

    Report Number
    8040227-2015-00008
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    July 23, 2015
    Report Date
    May 23, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT OF FEEDBACK CAME FROM THE DISTRIBUTOR, NOT THE USER FACILITY DIRECTLY. THE USER FACILITY NOTIFIED THE DISTRIBUTOR, WHICH NOTIFIED THE MANUFACTURER. ADDITIONAL NARRATIVE: PRODUCTION OF THE BLUNT FILL NEEDLE (#02463) WAS IMMEDIATELY HALTED SO A ROOT CAUSE ANALYSIS AND PRODUCT TESTING COULD BE CONDUCTED. PRODUCTION WAS HALTED IN AUGUST 2015 PENDING CONFIRMATION OF THE REPORTED CORING ISSUE. INITIAL TESTING TO DETECT THE RATE OF CORING COMPARED TO THE MARKET LEADER IN THE US WAS BASED ON ISO 7864:1993, STERILE HYPODERMIC NEEDLES FOR SINGLE USE, IN WHICH THERE WAS NO CORING DETECTED AMONG THE HMD (PART #02463- HMD) TEST POPULATION. FURTHER TESTING USING A TEST PROTOCOL THAT SIMULATED US CLINICAL USE OF THE DEVICE DETERMINED THE UNOLOK BLUNT FILL NEEDLE HAD A HIGHER CORING RATE THAN THE MARKET LEADER. THE MANUFACTURER VOLUNTARILY RECALLED SEVEN (7) LOTS FROM THE US MARKET (REF: USFDA RECALL # Z-0444-2016) WHICH WAS INITIATED ON NOVEMBER 4TH, 2015. THE DISTRIBUTOR, (B)(4) HAS SUPPORTED THIS ACTIVITY BY ADMINISTRATING THE RECALL AS THE US IMPORTER OF THE DEVICE. THE MANUFACTURER WAS UNABLE TO ADDRESS THE INSTANCE OF CORING ON THE BLUNT FILL NEEDLE TO ITS SATISFACTION AND HAS DISCONTINUED THE PRODUCT CITING THE INABILITY TO MATCH THE CORING RATE OF THE MARKET LEADER. SAMPLE NEEDLES WERE PREPARED TO ELIMINATE THE POTENTIAL CAUSE AS IDENTIFIED IN RCA FOR THE CORING OF RUBBER PARTICLE FROM THE RUBBER CLOSURE OF THE INJECTION VIAL. THESE SAMPLES WERE TESTED PER THE PROTOCOL TO SIMULATE US CLINICAL USE. CORING OF RUBBER PARTICLE WAS OBSERVED IN 01/244 PIERCING. THIS INDICATED THE ROOT CAUSE HAS NOT CORRECTLY BEEN IDENTIFIED, THUS MAKING THE CORRECTIVE ACTION TAKEN INEFFECTIVE. FURTHER PRODUCTION OF THE PRODUCT REMAINS SUSPENDED TILL THE TIME OF EFFECTIVE SOLUTIONS TO THE PROBLEM IS ESTABLISHED AND IMPLEMENTED. THE REPORTED FEEDBACK REGARDING THE FINISH OF THE CAP HAS BEEN NOTED AND CONSIDERED CUSTOMER PREFERENCE. THE MANUFACTURER HAS CONCLUDED THEIR INVESTIGATION, AND WE CONSIDER THIS ISSUE CLOSED.

    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. A COPY OF THIS REPORT IS ATTACHED. 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 OCCURENCE 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 (B)(4) LOTS DISTRIBUTED TO THE US MARKET SINCE 2014. THOSE BATCHES HAVE BEEN IDENTIFIED AS: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE CORING OF VIALS OCCURED. THE PHARMACY AND NURSING DEPARTMENT ALSO REPORTED THE CAP IS HARD TO PULL OFF AND IS SLIPPERY COMPARED TO THE PRODUCT THEY WERE USING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE CORING OF VIALS OCCURED. THE PHARMACY AND NURSING DEPARTMENT ALSO REPORTED THE CAP IS HARD TO PULL OFF AND IS SLIPPERY COMPARED TO THE PRODUCT THEY WERE USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8084 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD) 16561M

    Patients

    Seq Age Sex Outcome Treatment
    1