BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTICARE

    MDR report key: 3336059 · Received August 28, 2013

    Report

    Report Number
    2135402-2013-00002
    Event Type
    Other
    Date Received
    August 28, 2013
    Date of Event
    July 29, 2013
    Report Date
    August 27, 2013
    Manufacturer
    ULTIMED, INC.
    Product Code
    FMI
    PMA / PMN Number
    K100812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT RETURN ANY PRODUCT FOR ANALYSIS, LOT # 8130318. REVIEW OF DEVICE HISTORY FILES TO INCLUDE IN - PROCESS TESTING AND FINAL RELEASE PACKET INDICATED NO ISSUES WITH THIS LOT. THE ISO REQUIREMENT FOR THE AMOUNT OF FORCE TO REMOVE THE CANNULA FROM THE HUB IS EQUAL TO OR GREATER THAN 5 LBS. LOWEST PULL TEST ON IN PROCESS TESTING WAS 6.71 LBS WITH AN AVERAGE OF 11.10 LBS ON THAT SAME TEST SET. THE 9.98 LBS WAS THE MINIMUM ON THE FINAL LOT TESTING, WITH AN AVERAGE OF 12.09 LBS FOR THE TEST SET. TO DATE THERE IS ONE OTHER COMPLAINT ON THIS LOT HAVING TO DO WITH SHARPNESS. NOTE: THERE IS NO REQUIREMENT FOR SHARPNESS. PERFORMED PULL TEST 20 EA RETAIN SAMPLES. LOWEST PULL ON THE RETAIN SAMPLES WAS 9.33 LBS, WITH AN AVERAGE OF 12.67 LBS FOR THE TEST SET.

    Description of Event or Problem · 1

    CUSTOMER STATED ON MONDAY (B)(6) 2013 WAS GIVING HIMSELF A PM INJECTION. HE ADMINISTERED THE INJECTION AND WHEN COMPLETE HE PULLED AWAY THE PEN AND THE NEEDLE WAS NOT ATTACHED. THE NEEDLE REMAINED IN HIS SKIN, UNABLE TO GET IT OUT HE WENT TO THE EMERGENCY ROOM. CUSTOMER HAD NEEDLE SURGICALLY REMOVED ON WEDNESDAY (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421654 ULTICARE 12.7 MM 29 X 1/2" PEN NEEDLE FMI ULTIMED, INC. 8130318

    Patients

    Seq Age Sex Outcome Treatment
    1