BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGEN & AEROSOL THERAPY

    MDR report key: 3869086 · Received April 29, 2014

    Report

    Report Number
    1000317571-2014-00023
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    CONVATEC LIMITED
    Product Code
    BYF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. INVESTIGATION PERFORMED ON (B)(4) 2011 BY (B)(4) BASED ON THE EVAL OF SAMPLE REC'D ARE AS FOLLOWS: "FOLLOWING THE RESULTS OF THE O2% TESTING WE WERE SATISFIED THAT THE JET WAS NOT FUNCTIONALLY UNSAFE; HOWEVER, WE NEEDED TO ASCERTAIN WHY WE WERE GETTING PARTIALLY BLOCKED JETS. A THROUGH EXAMINATION UNDER MAGNIFICATION OF THE MOULDING TOOL REVEALED SOME DAMAGE TO ONE OF THE MOULD CAVITIES. THIS WAS NOT VISIBLE TO THE NAKED EYE. THIS DAMAGE MUST HAVE OCCURRED SHORTLY BEFORE OR DURING THE RUN THAT PRODUCED THE JETS USED IN THIS BATCH AS THE MFG RECORDS FROM PREVIOUS BATCHES DID NOT SHOW ANY ABNORMALITIES AND THERE HAVE BEEN NO ADVERSE INCIDENTS REPORTED SINCE THE MOULDING TOOL WAS REPAIRED IN (B)(4) 2010. THE MFG RECORDS FOR THIS BATCH DID NOT SHOW ANY MARKED ABNORMALITIES EITHER BUT THE QC INSPECTION LOOKS FOR O2% AND PARTIALLY BLOCKED JETS DO STILL PRODUCE 28% O2. OUR TOOL MAKER HAS NOT LOOKED AT THE TOOL AND HAS SUGGESTED A MODIFICATION TO PREVENT FURTHER INCIDENTS OF THIS NATURE. WE HAVE AGREED WITH HIS PROPOSAL AND THE TOOL MAKER IS NOW MAKING THE MODIFICATION WHICH WILL THEN BE VALIDATED BEFORE ANY FURTHER 28% JETS ARE RELEASED INTO PRODUCTION." NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY CONVATEC FOR COMPLAINTS REC'D FROM (B)(6) 2013. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE HOLE IN THE VALVE IS TOO SMALL PREVENTING THE CORRECT FLOW RATE OF AIR TO PASS THROUGH THE VENTURI VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256158 OXYGEN & AEROSOL THERAPY MASK, O2 LOW CONCENTRATION, VENTURI BYF CONVATEC LIMITED 1003MMUE 3120183-3

    Patients

    Seq Age Sex Outcome Treatment
    1