BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5098921 · Received September 23, 2015

    Report

    Report Number
    8040409-2015-00002
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    August 21, 2015
    Report Date
    September 23, 2015
    Manufacturer
    HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD)
    Product Code
    FMI
    PMA / PMN Number
    K945225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (DISTRIBUTOR) REPRESENTATIVES VISITED 3 HENRICO CAMPUSES IN (B)(4) AND WERE AVAILABLE TO CLINICAL STAFF ALL DAY TO OBTAIN FEEDBACK REGARDING THE UNOLOK PRODUCT. HENRICO FACILITIES ARE THE ONLY LOCATION REPORTING THE BREAKING ISSUE. A STANDARD QUESTIONNAIRE WAS REVIEWED WITH THE CLINICAL STAFF. WE RECEIVED BOTH POSITIVE AND NEGATIVE FEEDBACK FROM CLINICIANS. THE MAJORITY OF THE COMPLAINANTS WERE IN THE ANESTHESIA GROUP. IN REGARDS TO BREAKAGE, THE CLINICIANS ATTEMPTED, BUT WERE UNABLE TO BREAK NEEDLE IN FRONT OF MYCO PERSONNEL SIMULATING THE PROCESS WHICH THEY USE TO DRAW MEDICATIONS. ONE CLINICIAN WAS ABLE TO BEND THE NEEDLE USING AN EXTREME ANGLE DURING REMOVAL OF THE NEEDLE FROM THE VIAL. NEAR THE END OF THE SHIFT, ONE SURGERY TECHNICIAN BROUGHT A BROKEN NEEDLE SAMPLE TO MYCO PERSONNEL INDICATING THIS WAS BROKEN DURING THE CASE THAT WAS IN PROCESS/JUST COMPLETED THAT AFTERNOON. THIS SAMPLE WAS RETURNED TO THE MANUFACTURER. BROKEN AND UNBROKEN SAMPLES FROM THE COMPLAINANT WERE EXAMINED VISUALLY FOR ANY PHYSICAL DAMAGE TO THE NEEDLE CAP AND NEEDLE. NO DAMAGE TO THE NEEDLE CAP AND NEEDLE WAS OBSERVED. FURTHERMORE, THERE IS NO HISTORY OF COMPLAINT OF NEEDLE BREAKAGE AT HMD OVER 30YEARS OF PRODUCTION AND 1 BILLION OF NEEDLES PRODUCED. ADDITIONAL TESTING WAS PERFORMED. NEEDLES WERE PIERCED ON A RUBBER SHEET OF HARDNESS 75 SHORE A & 20 MM THICKNESS WHICH REQUIRES MORE THAN 33 N FORCE. NO NEEDLE BREAKAGE WAS OBSERVED DURING PIERCING OF RUBBER SHEET. NOTE: THE MAXIMUM REQUIRED FORCE TO PIERCE A RUBBER CLOSURE OF 55 SHORE A IS 6 N FORCE. IF THE NEEDLE DOES NOT BREAK AT 33N, IT WOULD NOT BREAK AT THE MINIMAL 6N REQUIRED TO PIERCE THE VIAL DURING STANDARD USAGE. ADDITIONAL TESTING WAS PERFORMED. THE MANUFACTURER (HMD) WAS ONLY ABLE TO REPRODUCE THE FAILURE BY PRESSING THE NEEDLE TUBE OVER A HARD SURFACE (E.G. TABLE TOP). THE BREAKING PATTERN OF THIS FAILURE WAS COMPARED WITH THE SAMPLE PROVIDED. THE BREAKING PATTERNS WERE IDENTICAL. THIS PROCESS WAS REPEATED WITH B.D NEEDLES AND REGULAR HYPODERMIC NEEDLES MANUFACTURED BY HMD WITH THE SAME RESULT. THE FORCE TO BREAK UNOLOK NEEDLES RANGES FROM 74.8N TO 82.3N. THE FORCE TO BREAK BD (COMPETITOR) NEEDLES RANGES FROM 79.1N TO 84.2N. THE FORCE IS COMPARABLE BETWEEN THE BRANDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 NEEDLE HUBS BROKE DURING A PROCEDURE. THE NEEDLE HUB BROKE AT THE BASE OF THE CANNULA. IT WAS ALSO REPORTED THAT THE BREAKING OCCURED MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629393 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD) 02463 17531D

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR