BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTICARE

    MDR report key: 5682448 · Received May 26, 2016

    Report

    Report Number
    2135402-2016-00011
    Event Type
    Malfunction
    Date Received
    May 26, 2016
    Date of Event
    September 16, 2015
    Report Date
    May 26, 2016
    Manufacturer
    ULTIMED, INC
    Product Code
    FMI
    PMA / PMN Number
    K100812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: CUSTOMER STATED NEEDLE DETACHED FROM HUB AND STAYED IN HIM, LOT # 8150514, ITEM # 0543. A TOTAL OF (B)(4) EA PEN NEEDLES WERE RELEASED ON 05/26/2015. THE (B)(4) UNITS WERE PACKED AND RELEASED AS FINISHED GOODS. THE (B)(4) EA PEN NEEDLES WERE SCRAPPED. THE (B)(4) UNITS WERE SHIPPED TO VARIOUS CUSTOMERS. NO PRODUCT WAS RETURNED WITH COMPLAINT. REVIEW OF DEVICE HISTORY FILES TO INCLUDE FINAL RELEASE PACKET INDICATED NO ISSUES WITH THIS LOT. LOWEST PULL FORCE DURING FINAL TESTING WAS 8.07 LBS, WITH AN AVERAGE OF 9.64 LBS FOR THE TEST SET. LOWEST PULL FORCE DURING IN PROCESS TESTING WAS 7.23 LBS, THE ACCEPTANCE CRITERIA FOR PULL FORCE TESTING IS GREATER THAN OR EQUAL TO 22N, (4.96 LBS). PERFORMED PULL FORCE TESTING ON TEN (B)(4) EA RETAIN SAMPLES. LOWEST PULL FORCE ON THE RETAINED SAMPLES WAS 8.14 LBS, WITH AN AVERAGE OF 9.23 LBS FOR THE TEST SET. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER STATED NEEDLE DETACHED FROM HUB AND STAYED IN HIM. HE HAD TO GO TO THE HOSPITAL TO GET IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338761 ULTICARE 4MM, 32G X 5/32" PEN NEEDLE FMI ULTIMED, INC 0543 8150514

    Patients

    Seq Age Sex Outcome Treatment
    1