BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE PAPER FILTER WITH INDICATOR

    MDR report key: 8290695 · Received January 30, 2019

    Report

    Report Number
    9610612-2019-00048
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    November 23, 2018
    Report Date
    January 31, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    FRG
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO.(B)(4). ) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. (B)(4). ). EXEMPTION NUMBER: E2014018. PMA/510K: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K944864.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. MANUFACTURING SITE EVALUATION: THIS IS A PRELIMINARY REPORT. ONLY PHOTOS ARE AVAILABLE FOR THE INVESTIGATION FROM QUALITY MANAGEMENT AND THE PRODUCTS WERE SENT TO THE MANUFACTURER FOR AN ANALYSIS. INVESTIGATION - THERE WERE VISIBLE HOLES IN THE FILTER. BATCH HISTORY REVIEW - THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE - ONLY PHOTOS ARE AVAILABLE AND IT IS HARDLY POSSIBLE TO DETERMINE AN EXACT CONCLUSION AND ROOT CAUSE. WE ASSUME THAT THE CAUSE OF THE FAILURE IS NOT PRODUCT RELATED. THERE IS THE POSSIBILITY THAT THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONALE - THIS REPORT WILL BE UPDATED WHEN WE RECEIVE A STATEMENT FROM THE MANUFACTURER. ACCORDING TO THE QUALITY STANDARD AND DHR FILES A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. DUE TO A SIMILAR ERROR PATTERN IN OTHER COMPLAINTS, THERE IS THE POSSIBILITY THAT THE HOLES WERE CREATED MECHANICALLY BY AN OBJECT OR BY FAULTY HANDLING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COUPLE SINGLE USE PAPER FILTERS. IT WAS NOTICED THAT THE FILTER PAPER IN AN INSTRUMENT CONTAINER HAD SMALL HOLES, AND THE SET WAS REJECTED DUE TO CONCERN ABOUT STERILITY. WHEN REVIEWING THE REST OF THE BATCH, IT WAS POSSIBLE TO VERIFY THAT THERE WERE MORE FILTERS WITH THE SAME DEFECT WHICH WERE NOT USED. IT WAS NOTED THAT THE MALFUNCTION WITH THE SET WAS FOUND PRIOR TO A PROCEDURE IN THE SAFETY CLINIC AND THE SCHEDULED SURGERY WAS POSTPONED. ON 21JAN2019 ADDITIONAL CLARIFICATION WAS RECEIVED. IT WAS CONFIRMED THAT THE PROCEDURE HAD NOT YET STARTED, THE PATIENT WAS NOT UNDER ANESTHESIA, AND THERE WAS NO SURGICAL DELAY. THIS REPORT REFERS TO THE SECOND FILTER WHICH WAS CONFIRMED UPON PRODUCT RETURN (07JAN2019). 9610612-2019-00023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83914 SINGLE USE PAPER FILTER WITH INDICATOR STERILE TECHNOLOGY FRG AESCULAP AG JK095 4509477053

    Patients

    Seq Age Sex Outcome Treatment
    1 INSTRUMENT CONTAINER