BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1213643-2018-01947

    MDR report key: 7596128 · Received June 13, 2018

    Report

    Report Number
    1213643-2018-01947
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Report Date
    June 13, 2018
    PMA / PMN Number
    P050038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT THEY USED AN EXPIRED ARISTA AH FLEXITIP DURING A PROCEDURE, THE LABELED EXPIRATION DATE ON THE PRODUCT WAS 12/28/2017. PER OUR RECORDS REVIEW THE PRODUCT WAS PROVIDED TO THE FACILITY ON (B)(6) 2015, APPROXIMATELY 2.5 YEARS PRIOR TO THE EXPIRATION DATE. ADDITIONALLY, THE EXPIRATION DATE IS IDENTIFIED ON EACH LEVEL OF THE PACKAGING. THIS EVENT IS CONFIRMED TO BE SOLELY A USE RELATED ERROR. NOTE: THERE IS NO ARISTA AH INCLUDED IN THIS PRODUCT, ITS INTENDED USE IS FOR APPLICATION ONLY. ARISTA AH IS SOLD SEPARATELY AND WOULD HAVE ITS OWN EXPIRY DATE. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NO SAMPLE RETURNED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARISTA AH FLEXITIP WAS RECENTLY USED DURING AN UNSPECIFIED PROCEDURE. AFTER THE CASE WAS COMPLETED, IT WAS NOTED THAT THE PRODUCT HAD EXPIRED IN (B)(6) 2017. AS REPORTED, THERE WAS NO PATIENT HARM OR ANY ADDITIONAL MEDICAL INTERVENTION. IT IS REPORTED THAT THE ARISTA AH FLEXITIP WAS TAKEN FROM THE USER FACILITY INVENTORY TO BE USED DURING THE CASE.

    Patients

    Seq Age Sex Outcome Treatment
    1