BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADER 1CC X 31G INS SYR

    MDR report key: 3012926 · Received February 25, 2013

    Report

    Report Number
    1915484-2013-00005
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Report Date
    January 23, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN INSULIN SYRINGE. THE CUSTOMER REPORTS WHILE PREPARING INSULIN, THE NEEDLE FELL OFF IN HER HAND. THE CUSTOMER FURTHER REPORTED THAT THE END USER STATED THAT HER HANDS ARE SHAKY AND SHE IS ROUGH ON THE NEEDLE; HOWEVER, HAD RECEIVED A 31 GAUGE, WHICH IS THINNER AND THE END USER IS NOT USED TO USING THAT SIZE GAUGE. THE END USER ALSO STATED THAT BECAUSE OF THIS, SHE COULD HAVE CAUSED THE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81059 LEADER 1CC X 31G INS SYR INSULIN SYRINGE FMF COVIDIEN 8881600101 201039

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK