BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INS SAF SYR 1/2 CC 29X1/2IN 100 HRDPK

    MDR report key: 1935687 · Received December 16, 2010

    Report

    Report Number
    1915484-2010-00045
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 3, 2010
    Manufacturer
    COVIDIEN
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH AN INSULIN SYRINGE. THE CUSTOMER STATES THAT AFTER ADMINISTERING THE INSULIN INJECTION, THE NURSE PULLED THE SAFETY BARREL UP TO LOCK IT IN PLACE AND THE BARREL PULLED STRAIGHT OFF THE SYRINGE. AS A RESULT, THE NURSE INCURRED A DIRTY NEEDLE STICK. IN RESPONSE TO THIS INCIDENT, THE NURSE AND THE RESIDENT WERE TAKEN TO THE HOSP FOR BLOOD WORK AND LABS. UPON THE ATTENDING PHYSICIAN'S REQUEST, THE NURSE WAS GIVEN A TETANUS SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INS SAF SYR 1/2 CC 29X1/2IN 100 HRDPK INSULIN SYRINGE MEG COVIDIEN 8881511136 027225

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK