BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE PAPER FILTER WITH INDICATOR

    MDR report key: 6673985 · Received June 28, 2017

    Report

    Report Number
    9610612-2017-00345
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 2, 2017
    Report Date
    August 7, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    OWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    (B)(6). IT WAS REPORTED THAT PARTICLES WAS FOUND INSIDE THE CONTAINERS THAT HAVE BEEN STERILIZED AS LONG AS TWO TO SIX MONTHS AGO. THE PARTICLES IN THE CONTAINERS ARE DARKER IN COLOR AND THE PARTICLES ARE SOLID. THE LIDS ALSO HAD SOME DUST ON THEM IN THE CREVICES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT VISUALLY. THE DUST IN QUESTION IS NOT AVAILABLE FOR INVESTIGATION, ONLY PICTURES WERE PROVIDED. THE SINGLE USE PAPER FILTER AND FILTER HOLDERS ARE USED, BUT NO DAMAGE CAN BE FOUND. THE CONTAINER BOTTOMS AND LIDS ARE ALSO IN USED CONDITION, SEVERAL SCRATCHES ON THE SURFACE, BUT NO SIGNIFICANT DAMAGES CAN BE FOUND. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. RATIONAL: THE PROVIDED PRODUCTS ARE ALL IN GOOD CONDITION, THUS WE EXCLUDE A MATERIAL OR MANUFACTURING RELATED ERROR. FURTHERMORE IT IS VERY UNLIKELY THAT SUCH A LARGE AMOUNT OF DUST CAN GET INTO A PROPERLY WORKING CONTAINER SYSTEM. IT IS CONCEIVABLE THAT SUCH AN AMOUNT OF IMPURITIES CAN GET INTO A CONTAINER, IF THE USER HAS FORGOTTEN TO INSTALL A PAPER FILTER BEFORE THE STERILIZATION PROCESS. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454951 SINGLE USE PAPER FILTER WITH INDICATOR DISPOSABLES CONTAINER SYSTEM OWP AESCULAP AG JK095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other