BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GVL STAT 2

    MDR report key: 6385028 · Received March 7, 2017

    Report

    Report Number
    9615393-2017-00037
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    November 21, 2016
    Report Date
    February 16, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    REF 76642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VERATHON INC., OF (B)(4), AND VERATHON MEDICAL ((B)(4), HAVE BECOME AWARE THAT ONE (1) LOT OF PRODUCT LABELED AS GVL® 2 STAT LOT GC32825 WAS PHYSICALLY PACKAGED WITH GVL® 1 STATS INSTEAD OF WITH GVL® 2 STATS. AS A RESULT, PATIENTS SELECTED FOR INTUBATION WITH A GVL® 2 STAT MAY INADVERTENTLY BE INTUBATED WITH A SMALLER GVL® 1 STAT. THE ISSUE HAS BEEN CONFIRMED TO BE ISOLATED TO ONLY THIS ONE LOT OF PRODUCT THAT WAS DISTRIBUTED FROM OCTOBER 2016 TO NOVEMBER 2016. THE PROBLEM WAS IDENTIFIED DURING A PROCEDURAL PRE-INSPECTION OF THE PRODUCT AT A CUSTOMER SITE. THE RISK TO PATIENT HEALTH FOR THIS PARTICULAR DEFECT HAS BEEN DETERMINED BY VERATHON'S MEDICAL ADVISORS TO BE REMOTE AND NOT LIKELY TO CAUSE ANY ADVERSE HEALTH CONSEQUENCES. WORLDWIDE, THERE HAVE BEEN NO REPORTED PATIENT INCIDENTS ASSOCIATED WITH THE MISLABELING OF THIS LOT TO DATE. VERATHON HAS ALREADY IMPLEMENTED ADDITIONAL INSPECTION CONTROLS AND WILL REPLACE ALL AFFECTED PRODUCT OF GLIDESCOPE GVL® 2 STAT LOT NUMBER GC32825 THAT REMAIN IN CONSIGNEES' INVENTORY WITH NEW PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UPON RECEIPT, ALL 10 UNITS IN THE BOX WERE GVL STAT 1 BLADES INSIDE A GVL STAT 2 PACKAGE. NO DELAY IN THE PROCEDURE OR USE OF A BACK-UP DEVICE WAS REPORTED. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165542 GVL STAT 2 LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0574-0027 GC32825

    Patients

    Seq Age Sex Outcome Treatment
    1