BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE URINARY LEG BAG

    MDR report key: 7120539 · Received December 15, 2017

    Report

    Report Number
    7120539
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 17, 2017
    Report Date
    December 12, 2017
    Manufacturer
    OWENS & MINOR DISTRIBUTION INC.
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S BILATERAL NEPHROSTOMY TUBES WERE EXCHANGED AT THIS FACILITY BY INTERVENTIONAL RADIOLOGY (IR). THE PATIENT THEN WENT TO A NURSING HOME. PATIENT READMITTED HERE A FEW DAYS LATER, AND HER CREATININE THE NEXT DAY WAS UP TO 7.7. THE IR PHYSICIAN'S ASSISTANT (PA) NOTICED THAT THE PATIENT'S NEPHROSTOMY TUBE BAG HAD BEEN CONNECTED UPSIDE DOWN, AND THEREFORE PATIENT'S URINE WAS NOT DRAINING. THIS IS WHAT CAUSED THE PATIENT'S CREATININE LEVEL TO INCREASE. MANY STAFF MEMBERS HAD SEEN THIS PATIENT AND HAD NOT NOTICED THAT THIS BAG WAS UPSIDE DOWN - THIS IS DUE TO A DESIGN FAILURE IN WHICH EITHER END OF THE BAG IS ABLE TO CONNECT TO THE PATIENT'S TUBING. ALTHOUGH THERE IS A LABEL ON THE BAG MARKED "TOP" - IT DOES NOT STAND OUT, AND CANNOT BE SEEN IF THE BAG IS FLIPPED AROUND, ETC. EVEN THOUGH THE TUBES AT BOTH ENDS LOOK SLIGHTLY DIFFERENT, IT IS CONCERNING THAT BOTH ARE ABLE TO CONNECT WHICH IS WHY IT WAS NOT PICKED UP ON RIGHT AWAY WHEN THE PATIENT CAME BACK TO THE HOSPITAL. THE BAG WAS FLIPPED UPSIDE DOWN AT THE NURSING HOME, NOT AT THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899375 MEDICHOICE URINARY LEG BAG COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER KNX OWENS & MINOR DISTRIBUTION INC. SLB0019 1608KN05A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other