BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIPERSLIDE LUBRICANT

    MDR report key: 18799310 · Received February 27, 2024

    Report

    Report Number
    MW5152085
    Event Type
    Other
    Date Received
    February 27, 2024
    Date of Event
    February 15, 2024
    Report Date
    February 16, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCX
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VIPERSLIDE 100 ML (LUBRICANT) MADE BY CSI (CARDIOVASCULAR SYSTEMS INC.) LOOKS NEARLY IDENTICAL TO INTRALIPID 20% 100 ML MADE BY FRESENIUS KABI. WHEN THIS CATH LAB PRODUCT (VIPERSLIDE) WAS ERRONEOUSLY RETURNED TO THE PHARMACY IT WAS NEARLY CONFUSED WITH INTRALIPID AND DISPENSED TO THE NEONATAL INTENSIVE CARE UNIT FOR NUTRITION SUPPORT, WHICH COULD HAVE BEEN CATASTROPHIC. THIS MISTAKE DID NOT REACH ANY PATIENT BUT STRONGLY SUGGEST THAT SOME PACKAGING CHANGING BE REQUIRED TO IMPROVE PATIENT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898338 VIPERSLIDE LUBRICANT CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NAME: INTRALIPID.STRENGTH: 20%.MANUFACTURER/COMPOUNDER: FRESENIUS KABI.NDC # OR UNIQUE ID: 6521953101.DOSE OR AMOUNT: 100ML.