BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAL VENOUS CATHETERIZATION

    MDR report key: 3811831 · Received May 9, 2014

    Report

    Report Number
    MW5036081
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I AM AN ANESTHESIOLOGIST AT (B)(6) HOSPITAL IN (B)(6). I NOTICED TODAY THAT IN OUR ANESTHESIA WORKROOM AND IN SEVERAL OF OUR OPERATING ROOMS, WE HAVE ARROW AK-04700 14GA CENTRAL VENOUS CATHETERIZATION "CENTRAL LINE" KITS THAT HAVE NO DATE OF MANUFACTURE OR EXPIRATION DATE PRINTED ON THEM. WE STOCK AND USE SEVERAL MODELS OF ARROW "CENTRAL LINE" KITS IN VERY SIMILAR PACKAGES, AND ALL OF THE OTHER ONES HAVE EXPIRATION DATES. WE ROUTINELY PULL AND DISCARD MEDICAL DEVICES THAT ARE ON THE VERGE OF EXPIRATION, BUT I WAS TOLD THAT BECAUSE THESE KITS HAVE NO EXPIRATION DATE PRINTED ON THEM, WE DO NOT EVER HAVE TO DISCARD THEM. THAT DOESN'T SEEM REASONABLE TO ME. THE LOT NUMBER ON ONE OF THESE KITS IS RF3111258. COULD SOMEONE PLEASE EMAIL ME AT (B)(6) TO LET ME KNOW WHETHER THESE DO OR DO NOT EVER NEED TO BE DISCARDED? THESE ARE PRE-PACKAGED STERILE PROCEDURE TRAYS. IF YOU HAVE ANY QUESTIONS, PLEASE DO NOT HESITATE TO CALL ME AT (B)(6), ANESTHESIOLOGIST. I DO NOT KNOW OF ANY PATIENT ON WHOM OTHER KITS WITHOUT EXPIRATION DATES HAVE BEEN USED. THIS IS A DEVICE WE USE INFREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281294 CENTRAL VENOUS CATHETERIZATION CATHETER FOZ ARROW INTERNATIONAL AK-04700 RF3111258

    Patients

    Seq Age Sex Outcome Treatment
    1