BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER RECANALIZATION CATHETER

    MDR report key: 4810824 · Received May 22, 2015

    Report

    Report Number
    2020394-2015-00661
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K092175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FURTHER CLINICAL REVIEW WAS PERFORMED AND IDENTIFIED THIS EVENT TO BE MDR REPORTABLE PURSUANT TO 21 CFR PART 803. THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE DEVICE WAS NOT RETURNED FOR EVAL; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFO. IT IS UNK IF PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS AND PRECAUTIONS: PRIOR TO USE, THE PACKAGING AND PRODUCT SHOULD BE INSPECTED FOR SIGNS OF DAMAGE. NEVER USE DAMAGED PRODUCT OR PRODUCT FROM A DAMAGED PACKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECANALIZATION CATHETER FLUSH PORT WAS CRACKED UPON REMOVAL FROM THE PACKAGING. REPORTEDLY, AN ATTEMPT WAS MADE TO FLUSH THE CATHETER; HOWEVER, SALINE WAS OBSERVED EXITING THE CRACK. ANOTHER RECANALIZATION CATHETER WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335398 CROSSER RECANALIZATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. FCWL10017

    Patients

    Seq Age Sex Outcome Treatment
    1