BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER MINI KIT

    MDR report key: 8851814 · Received August 1, 2019

    Report

    Report Number
    1625685-2019-00081
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 2, 2019
    Report Date
    May 17, 2022
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    PMA / PMN Number
    K160450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP EMDR FOR DEVICE EVALUATION. ONE SAMPLE WAS RECEIVED FOR EVALUATION. THE FAILURE WAS CONFIRMED. LOT IDENTIFICATION WAS NOT OBSERVED AND CONSEQUENTLY, A DHR REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION PROVIDED, A PROBABLE ROOT CAUSE WAS NOT DETERMINED FOR THIS INVESTIGATION. DURING THE ANALYSIS PERFORMED RELEVANT TO THE FAILURE MODE, IT WAS NOT POSSIBLE TO IDENTIFY ANY PROBABLE ROOT CAUSE REGARDING THE ELEMENTS ANALYZED. THIS INSTANCE WILL BE ENTERED INTO THE TRACKING SYSTEM AND WILL BE TRACKED AND TRENDED FOR FUTURE OCCURRENCES AS A PART OF THE MONTHLY QUALITY DATA ANALYSIS (QDA).

    Description of Event or Problem · 0

    I WANT TO INFORM YOU ABOUT A DEFECTIVE VALVE. THE VALVE WAS BROKEN WHEN USING THE CAP. SAFETY CLAMP WAS USED. 04SEPT2019 THE RCC VERIFIED THE SAMPLE HAD BEEN SENT HOWEVER THE PLANT WAS NOT ABLE TO LOCATE. THE SAMPLE IS CONSIDERED LOST IN TRANSIT. DMH.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    I WANT TO INFORM YOU ABOUT A DEFECTIVE VALVE. THE VALVE WAS BROKEN WHEN USING THE CAP. SAFETY CLAMP WAS USED. VALVE WAS CHANGED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645811 PLEURX PLEURAL CATHETER MINI KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other