BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER MINI KIT

    MDR report key: 6753984 · Received July 31, 2017

    Report

    Report Number
    1625685-2017-00303
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    May 24, 2017
    Report Date
    October 27, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    PMA / PMN Number
    K121849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOLLOW UP EMDR FOR DEVICE EVALUATION. THE SAMPLE VALVE RETURNED SHOWED EVIDENCE OF THE INTERNAL BLUE SILICONE PARTS INSIDE TO BE TWISTED WHICH WOULD HAVE ALLOWED LEAKAGE AROUND THE BI-DIRECTIONAL VALVE. NO LOT NUMBER WAS SUBMITTED, THEREFORE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. UPON EXAMINATION OF THE PLEURX VALVE IT WAS EASILY SEEN THAT THE BLUE SILICONE COMPONENT(S) INSIDE THE VALVE BODY WERE TWISTED WHICH WOULD ALLOW FLUID TO HAVE A PASSAGE AROUND THE BI-DIRECTIONAL VALVE (LEAKAGE). FURTHER EXAMINATION SHOWED THAT ONE OF THE COMPONENTS INSIDE THE VALVE WAS MISSING. THE MISSING PART WOULD CERTAINLY PROVIDE AN OPPORTUNITY FOR THE ACCESS TIP (WHEN INSERTED) TO PUSH THE DISC OUT OF PLACE AS THE SAMPLE INDICATES. THE VALVE IS PROVIDED TO US COMPLETELY ASSEMBLED WITH TWO BLUE SILICONE PARTS WHICH FUNCTION AS THE BI-DIRECTIONAL VALVE. THIS VALVE APPEARED TO HAVE BEEN ASSEMBLED WITHOUT ONE OF THE BLUE SILICONE COMPONENTS. A QUALITY NOTIFICATION IS BEING SENT TO THE VENDOR.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    SAFETY VALVE IS LEAKING. PATIENT DOESN'T WANT A NEW IMPLANTATION. HOSPITAL STAFF AND SALES REPORTER WERE TRYING TO DRAIN WITH LOCKABLE DRAINAGE LINE ((B)(4)). THEY MENTIONED IT FELT LIKE SOMETHING ELSE IS INSIDE THE VALVE. BLUE SILICONE PART INSIDE THE VALVE IS VISIBLE WHILE CONNECTING VALVE WITH A ACCESS TIP. SAFETY VALVE HAD TO BE CHANGED. NEITHER PATIENT INJURY NOR MEDICAL INTERVENTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536321 PLEURX PLEURAL CATHETER MINI KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 50-7050

    Patients

    Seq Age Sex Outcome Treatment
    1