BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREE-WAY PLASTIC STOPCOCK

    MDR report key: 6116168 · Received November 21, 2016

    Report

    Report Number
    1820334-2016-01348
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    June 27, 2017
    Manufacturer
    COOK INC
    Product Code
    KGZ
    UDI-DI
    00827002002197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, AND VISUAL INSPECTION OF THE RETURNED DEVICES WAS PERFORMED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF TWO UNOPENED THREE-WAY PLASTIC STOPCOCKS WAS PERFORMED. THE USED, FAILED DEVICE WAS NOT RETURNED DUE TO CONTACT WITH CHEMOTHERAPY PRODUCTS. A LEAK TEST WAS PERFORMED AND BOTH DEVICES FAILED. ALSO, BOTH DEVICES EXHIBITED A 2MM CRACK IN THE BASE OF THE DEVICE. THE DEVICE EXAMINATION FOR THE THIRD DEVICE WHICH WAS RECEIVED OPENED IS DOCUMENTED UNDER MANUFACTURER REPORT NUMBER 1820334-2016-01342. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THIS IS ONE OF TWO REPORTED COMPLAINTS FOR THIS LOT NUMBER FROM THE SAME CUSTOMER. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, THERE IS NOT ENOUGH EVIDENCE TO CONFIRM A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ADMINISTRATION OF HEPATIC CHEMOEMBOLIZATION WITH A MIXTURE OF LIPIDOL (PDC) AND ADRIBLASTINE, A DROP OF THE MIXTURE FELL ON THE TABLE FIELD WITHOUT CONTACTING THE OPERATOR. THE CHEMOTHERAPY WAS NOT GIVEN IN FULL. REPORTEDLY THERE WAS NO CONTACT WITH THE SKIN. THE RETAINED DEVICES HAVE NOT BEEN IN CONTACT WITH CHEMOTHERAPY PRODUCTS. SEVERAL ATTEMPT HAVE BEEN MADE FOR FURTHER INFORMATION TO VERIFY IF THIS WAS PRIOR TO USE AS REPORTED AND TO VERIFY IF THE PATIENT RECEIVED THE FULL CHEMOTHERAPY TREATMENT. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768400 THREE-WAY PLASTIC STOPCOCK KGZ ACCESSORIES, CATHETER KGZ COOK INC N/A 00827002002197

    Patients

    Seq Age Sex Outcome Treatment
    1