BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROBAC FILTER REINF MEMBRANE

    MDR report key: 2682329 · Received August 1, 2012

    Report

    Report Number
    2936999-2012-00332
    Event Type
    Malfunction
    Date Received
    August 1, 2012
    Date of Event
    June 28, 2012
    Report Date
    July 3, 2012
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    CAH
    PMA / PMN Number
    K944124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNING OF THE DEVICE HAS BEEN REQUESTED. IF THE DEVICE IS RECEIVED, IT WILL BE EVALUATED AND A FOLLOW UP MEDWATCH WILL BE SUBMITTED. REQUEST FOR ADD'L INFO HAS BEEN REQUESTED. THE PRODUCT, (B)(4) SPIROBAC FILTER REINFORCED MEMBRANE X25 IS NOT SOLD IN US HOWEVER, A SIMILAR DESIGN IS DISTRIBUTED IN THE US UNDER PN (B)(4) SPIROBAC FILTER FLOW PACK. THE 510K NUMBER FOR THE (B)(4) IS K944124.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT DURING LUNG FUNCTION TESTING, SOME TISSUE OF THE FILTER WAS INHALED. ACCORDING TO THE REPORTER, THE PT HAD TO COUGH VERY HARD IN ORDER TO REMOVE THE TISSUE OUT OF THE PT. THE CUSTOMER REPORTED THAT THERE WAS NO CHANGE IN THE PT CONDITION DUE TO THE EVENT AND THAT NO MEDICAL INTERVENTION WAS NEEDED. FURTHER INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIROBAC FILTER REINF MEMBRANE SPIROBAC FILTER CAH COVIDIEN/FORMERLY TYCO HEALTHCARE 120302353X

    Patients

    Seq Age Sex Outcome Treatment
    1