BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE FILTER FOR CONTAINER

    MDR report key: 11947869 · Received June 7, 2021

    Report

    Report Number
    9610612-2021-00425
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 4, 2021
    Report Date
    August 4, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    FRG
    PMA / PMN Number
    K792558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH JK090 - REUSABLE FILTER FOR CONTAINER. ACCORDING TO THE COMPLAINT DESCRIPTION, ONE OF THE 2 FILTERS GUARANTEEING THE STERILITY OF ALL THE INSTRUMENTS WAS NON-COMPLIANT (TORN AT THE LEVEL OF THE INSERTION RING). THE USE OF ALL THE INSTRUMENTS IN THE BOX WAS THEREFORE NOT POSSIBLE. IT WAS NECESSARY TO URGENTLY SEEK NEW BOXES WITHOUT KNOWING IF THE EQUIPMENT WAS AVAILABLE IN THE ARSENAL: THE PATIENT WAS ALREADY ANESTHETIZED. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849501 REUSABLE FILTER FOR CONTAINER STERILE TECHNOLOGY FRG AESCULAP AG JK090

    Patients

    Seq Age Sex Outcome Treatment
    1