BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAGLIDE LUBRICANT

    MDR report key: 2132689 · Received June 9, 2011

    Report

    Report Number
    MW5021001
    Event Type
    Injury
    Date Received
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON ONE SCIENTIFIC
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ROTAGLIDE IS A LUBRICANT MANUFACTURED FOR BOSTON SCIENTIFIC CORP. THIS LUBRICANT IS USED FOR WIRES/STENTS FOR VASCULAR PROCEDURES. THIS MORNING, ONE OF OUR CRNAS WAS GETTING HER ANESTHESIA CART READY AND NOTICED A VIAL ON HER CART THAT APPEARED TO BE PROPOFOL - THANKFULLY SHE CHECKED THE MEDICATION. IT TURNED OUT TO BE THIS PRODUCT ROTAGLIDE. YESTERDAY A PHYSICIAN ASKED FOR A LUBRICANT AND A PHARMACEUTICAL REP (UNK WHY THIS REP WAS IN THE OPERATING ROOM) BROUGHT THIS INTO THE ROOM TO SHOW THE PHYSICIAN AND IT WAS LEFT IN THE ROOM ON THE ANESTHESIA CART AND WE ARE GUESSING IT INADVERTENTLY STAYED ON THE ANESTHESIA CART DURING TURNOVER. THIS PRODUCT LOOKS EXACTLY LIKE PROPOFOL. IT IS WHITE, MILKY, WITH THE SAME SIZE VIAL, CAP COLOR, AND LABEL COLOR AND IT DOES NOT SAY NOT FOR IV USE. THERE IS ALSO (B)(6) INSCRIPTIONS ALL OVER THIS VIAL, BUT IT STATES IT IS MANUFACTURED FOR BOSTON SCIENTIFIC CORP, (B)(4). OUR SAFETY TEAM HAD SEARCHED ONLINE AND STATED THERE WAS AN INCIDENT LIKE THIS MANY YEARS AGO AND 4 PTS DIED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTAGLIDE LUBRICANT LUBRICANT MCX BOSTON ONE SCIENTIFIC NR90061

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O