BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URINARY DRAINAGE BAG

    MDR report key: 6112361 · Received November 18, 2016

    Report

    Report Number
    1018233-2016-01659
    Event Type
    Injury
    Date Received
    November 18, 2016
    Report Date
    December 9, 2016
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    RECEIVED 1 USED SAMPLE PORT WITH THE CATHETER AND PART OF THE DRAINAGE TUBING STILL ATTACHED. THE REPORTED EVENT WAS CONFIRMED; HOWEVER, THE CAUSE IS UNKNOWN. THE VISUAL INSPECTION NOTED THE SAMPLE PORT DISCONNECTED EASILY. THE VISUAL INSPECTION ALSO NOTED THAT THE BLUE STEM LUER AND THE BODY CAP WERE RETURNED DISCONNECTED FROM THE REST OF THE CONNECTOR, AND THE BLUE STEM LUER WAS RETURNED WITH THE REST OF THE SAMPLE PORT BODY. EVIDENCE OF ULTRASONIC WELDING WAS OBSERVED IN THE SAMPLE PORT CAP. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: " VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OF SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTIONS OR SURFACE DETERIORATION IS OBSERVED DO NOT USE." (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAMPLE PORT STEM (BLUE GROMMET) DISCONNECTED FROM THE BAG AND LEAKED URINE. THE DRAIN BAG WAS IN USE FROM (B)(6) 2016. THE PATIENT TESTED POSITIVE FOR A CAUTI (CATHETER ASSOCIATED URINARY TRACT INFECTION) AND WAS TREATED WITH ANTIBIOTICS. THE COMPLAINANT STATED ALCOHOL WIPES WERE NOT BEING USED ON THE SAMPLE PORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAMPLE PORT STEM (BLUE GROMMET) DISCONNECTED FROM THE BAG AND LEAKED URINE. THE DRAIN BAG WAS IN USE FROM (B)(6) 2016 UNTIL (B)(6) 2016. THE PATIENT TESTED POSITIVE FOR A CAUTI (CATHETER ASSOCIATED URINARY TRACT INFECTION) AND WAS TREATED WITH ANTIBIOTICS. THE COMPLAINANT STATED ALCOHOL WIPES WERE NOT BEING USED ON THE SAMPLE PORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAMPLE PORT STEM (BLUE GROMMET) DISCONNECTED FROM THE BAG AND LEAKED URINE. THE DRAIN BAG WAS IN USE FROM (B)(6) 2016. THE PATIENT TESTED POSITIVE FOR A CAUTI (CATHETER ASSOCIATED URINARY TRACT INFECTION) AND WAS TREATED WITH ANTIBIOTICS. THE COMPLAINANT STATED ALCOHOL WIPES WERE NOT BEING USED ON THE SAMPLE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762747 URINARY DRAINAGE BAG DRAIN BAG KNX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention