BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP INTERMITTENT CATHETER TRAY

    MDR report key: 16761547 · Received April 18, 2023

    Report

    Report Number
    1018233-2023-02639
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 27, 2023
    Report Date
    September 5, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741183218
    PMA / PMN Number
    K000723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS CONFIRMED MANUFACTURING RELATED. VISUAL EVALUATION NOTED RECEIVED 1 SURESTEP INTERMITTENT CATHETER WITH NO EYELETS PRESENT. THEREFORE, PRODUCT DOES NOT MEET SPECIFICATIONS WHICH STATES "MISSING COMPONENTS ARE NOT ALLOWED." ALTHOUGH AN EXACT ROOT CAUSE COULD NOT BE DETERMINED A POTENTIAL ROOT CAUSE COULD BE: THERMOCOUPLE OOC: - THERMOCOUPLE FAILURE . ELECTRICAL FAILURE. - INCONSISTENT TEMP/HUM PROFILE. DHR REVIEW DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELLING REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS CONFIRMED MANUFACTURING RELATED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NURSE ATTEMPTED TO STRAIGHT CATHETER A PATIENT ON (B)(6) 2023, THE CATHETER DID NOT HAVE ANY OPENINGS AT THE END OF THE TUBE FOR FLUID TO FLOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NURSE ATTEMPTED TO STRAIGHT CATHETER A PATIENT ON (B)(6) 2023, THE CATHETER DID NOT HAVE ANY OPENINGS AT THE END OF THE TUBE FOR FLUID TO FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624266 SURESTEP INTERMITTENT CATHETER TRAY CATHETER TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 INTS14 NGGY1090 00801741183218

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other