BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLANGIOGRAPHY CATHETER

    MDR report key: 3815348 · Received May 16, 2014

    Report

    Report Number
    2015691-2014-01167
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    GBZ
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE CHOLANGIOGRAPHY CATHETER IN THE PACKAGING AND THE CAP SHRINK SEAL HAD BEEN OPENED. THE CATHETER DID NOT APPEAR USED. THE CATHETER WAS REMOVED AND FOUND TO HAVE WHAT APPEARED TO BE GRAY FOAM STUCK TO THE RED SHRINK TUBING THAT IS BONDED TO THE STOPCOCK. THE FOAM APPEARED TO BE STUCK TO THE ADHESIVE. THE ADHESIVE DID NOT APPEAR TO HAVE COME FROM THE STOPCOCK BOND SITE. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OPERATING ROOM HAD A 4 FRENCH CHOLANGIOGRAM CATHETER THAT HAS WHAT APPEARED TO BE GREY FOAM STUCK TO IT. IT WAS INDICATED THAT THE GREY FOAM WAS ALREADY ON THE CATHETER BEFORE THEY OPENED IT BUT DIDN'T NOTICE IT UNTIL AFTER OUTER SEAL WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294359 CHOLANGIOGRAPHY CATHETER CATHETER, CHOLANGIOGRAPHY GBZ EDWARDS LIFESCIENCES PR 420404F 59429229

    Patients

    Seq Age Sex Outcome Treatment
    1