BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT DISPOSABLE FILTERS

    MDR report key: 12037189 · Received June 21, 2021

    Report

    Report Number
    2523190-2021-00129
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Report Date
    August 17, 2021
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KCT
    PMA / PMN Number
    K072563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE 775200 JARIT DISPOSABLE FILTERS WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - THE RETURNED FILTERS ARE IN UNUSED CONDITION WITH THE CENTER PIN HOLE OFF CENTER DUE TO ALIGNMENT ERROR. ROOT CAUSE - THE REPORTED COMPLAINT IS CONFIRMED. THE DEVICE IS IN USED CONDITION WITH THE CENTER PIN HOLE OFF CENTER DUE TO ALIGNMENT ERROR. INSPECTION HAS BEEN INITIATED FOR THIS ISSUE. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE INSERTION OF THE HOLE IN THE JARIT DISPOSABLE FILTER (775200) WAS NOT IN THE CENTER OF THE CIRCLE; IT WAS MISALIGNED WHEN ATTACHED TO THE LID, AND STERILIZATION WAS INCOMPLETE. THERE WAS NO PATIENT INJURY AND DELAY IN SURGERY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934355 JARIT DISPOSABLE FILTERS N/A KCT INTEGRA YORK, PA INC. 2002024

    Patients

    Seq Age Sex Outcome Treatment
    1