BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 3841402 · Received May 30, 2014

    Report

    Report Number
    1625685-2014-00123
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    PMA / PMN Number
    K121849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. IF ADDITIONAL INFORMATION AND/OR THE SAMPLE IS MADE AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. CONSEQUENTLY, THE QUALITY OF THE PRODUCT COULD NOT BE EVALUATED. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. EVERY CATHETER ASSEMBLY IS SUBJECTED TO EXTENSIVE FUNCTIONAL TESTING AND INSPECTION DURING THE ASSEMBLY PROCESS TO VERIFY PERFORMANCE AND CONFORMITY TO ENGINEERING DESIGN. LIKEWISE, A REVIEW OF ALL MANUFACTURING METHODS AND PERSONNEL INVOLVED IN THE ASSEMBLY OF THE DEVICE DETERMINED THERE WAS NO CONTRIBUTION FROM EITHER TO THE REPORTED CONDITION. A REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INVOLVED COULD NOT BE PERFORMED AS LOT NUMBER INFORMATION WAS NOT AVAILABLE. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AS THE SAMPLE WAS NOT AVAILABLE FOR ANALYSIS. ALTHOUGH THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE MOST ROOT CAUSE COULD NOT BE DETERMINED WITHOUT A SAMPLE BEING PROVIDED, THE MANUFACTURING PLANT WILL CONTINUE TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY ACTIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE CUSTOMER ((B)(6)) INDICATED THAT THE PLEURAL CATHETER WAS PLACED ON (B)(6) 2014. NO DEFECT WAS NOTED IN THE OR. THE PATIENT AND THE CUSTOMER FIRST NOTED THAT THE CAP WAS VERY DIFFICULT TO REPLACE IMMEDIATELY. THE CONNECTION TO THE VALVE JUST DID NOT SEEM RIGHT, AND IT DID NOT CLICK ON EASILY. THE PATIENT HAS NEVER HAD DIFFICULTY DRAINING THE CATHETER. AFTER THE VALVE STEM CAME OUT, THE PATIENT IMMEDIATELY PUT IT BACK IN AS TIGHTLY AS POSSIBLE AND THE CATHETER WAS NOT REPLACED. THE PATIENT HAS HAD NO FURTHER ISSUES BUT THE CAPS REMAIN SOMEWHAT DIFFICULT TO REPLACE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VALVE BECAME DETACHED FROM THE CATHETER BECAUSE THE PATIENT WAS TRYING SO HARD TO GET THE CAP TO CONNECT PROPERLY. THE CUSTOMER STATES THAT PRIOR TO THE NAME BEING PRINTED ON THE VALVE, THEY WERE FINE, BUT SINCE THEN THE PLEURX VALVE CAPS ARE HARD TO GET ON THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318715 PLEURX PLEURAL CATHETER KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 50-7000B

    Patients

    Seq Age Sex Outcome Treatment
    1