BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESTEP FOLEY TRAY - BARDEX I.C. WITH HYDROGEL AND BACTI-GUARD SILVER ALLOY, 14

    MDR report key: 6039520 · Received October 19, 2016

    Report

    Report Number
    1018233-2016-01438
    Event Type
    Injury
    Date Received
    October 19, 2016
    Report Date
    December 1, 2016
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    MJC
    PMA / PMN Number
    K910318
    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. PHOTO SAMPLE RECEIVED.

    Additional Manufacturer Narrative · 1

    RECEIVED 1 USED BLUE STEM LUER PORT ONLY. THE VISUAL INSPECTION NOTED THAT THE BLUE STEM LUER, AND THE BODY CAP WERE RETURNED DISCONNECTED FROM THE REST OF THE CONNECTOR AND BAG. THE BLUE STEM LUER WAS RETURNED WITHOUT 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). PHOTO SAMPLE RECEIVED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. CORRECTION = MANUFACTURER SITE. 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. PHOTO SAMPLE RECEIVED.

    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. PHOTO SAMPLE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAMPLE PORT DISCONNECTED. THE COMPLAINANT STATED THAT DUE TO THE DISCONNECTIONS OF THE SAMPLE PORT, THE PATIENT ALLEGEDLY HAS EXPERIENCED INFECTIONS. IT WAS ALSO REPORTED THAT A DUALCAP, INTENDED FOR VASCULAR ACCESS IV LINES, WAS PLACED ON TOP OF THE SAMPLE PORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAMPLE PORT DISCONNECTED. THE COMPLAINANT STATED THAT DUE TO THE DISCONNECTIONS OF THE SAMPLE PORT, THE PATIENT ALLEGEDLY EXPERIENCED A URINARY TRACT INFECTION, WHICH WAS TREATED WITH ANTIBIOTICS. IT WAS ALSO REPORTED THAT A DUALCAP, INTENDED FOR VASCULAR ACCESS IV LINES, WAS PLACED ON TOP OF THE SAMPLE PORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAMPLE PORT DISCONNECTED. THE COMPLAINANT STATED THAT DUE TO THE DISCONNECTIONS OF THE SAMPLE PORT, THE PATIENT ALLEGEDLY EXPERIENCED A URINARY TRACT INFECTION, WHICH WAS TREATED WITH ANTIBIOTICS. IT WAS ALSO REPORTED THAT A DUALCAP, INTENDED FOR VASCULAR ACCESS IV LINES, WAS PLACED ON TOP OF THE SAMPLE PORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAMPLE PORT DISCONNECTED. THE COMPLAINANT STATED THAT DUE TO THE DISCONNECTIONS OF THE SAMPLE PORT, THE PATIENT ALLEGEDLY EXPERIENCED A URINARY TRACT INFECTION, WHICH WAS TREATED WITH ANTIBIOTICS. IT WAS ALSO REPORTED THAT A DUALCAP, INTENDED FOR VASCULAR ACCESS IV LINES, WAS PLACED ON TOP OF THE SAMPLE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693027 SURESTEP FOLEY TRAY - BARDEX I.C. WITH HYDROGEL AND BACTI-GUARD SILVER ALLOY, 14 FOLEY CATHETER TRAY MJC PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention