BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® INLAY OPTIMA® URETERAL STENT

    MDR report key: 17316275 · Received July 13, 2023

    Report

    Report Number
    1018233-2023-05127
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 24, 2023
    Report Date
    October 25, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FAD
    UDI-DI
    00801741015687
    PMA / PMN Number
    K043193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS CONFIRMED CAUSE UNKNOWN. VISUAL EVALUATION NOTED RECEIVED 1 URETERAL STENT IN OPEN PACKAGING. PACKAGE LABEL STATES STENT, PUSH CATHETER, AND PIG TAIL STRAIGHTER HOWEVER ONLY STENT WAS RECEIVED. THEREFORE, IT IS UNKNOWN THE COMPONENT WAS MISSING DUE TO RECEIVING THE SAMPLE IN OPEN PACKAGING. ALTHOUGH AN EXACT ROOT CAUSE COULD NOT BE DETERMINED A POTENTIAL ROOT CAUSE COULD BE INCORRECT OPERATION. A DHR REVIEW DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE LABELLING REVIEW IS NOT REQUIRED AS LABELLING WOULD NOT HAVE PREVENTED THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO INSERTION OF THE URETERAL STENT, THE DOCTOR OPENED THE PACKAGE AND FOUND THAT THE PROPELLER WAS MISSING (LACK OF COMPONENT). THEREFORE, THE DEVICE WAS NOT USED, CAUSING NO IMPACT ON THE PATIENT. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 24AUG2023, STATED THAT THE PROPELLER MEANT THE COMPONENT THAT WAS USED TO PUSH THE STENT TO ADVANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO INSERTION OF THE URETERAL STENT, THE DOCTOR OPENED THE PACKAGE AND FOUND THAT THE PROPELLER WAS MISSING (LACK OF COMPONENT). THEREFORE, THE DEVICE WAS NOT USED, CAUSING NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281976 BARD® INLAY OPTIMA® URETERAL STENT URETERAL STENT FAD C.R. BARD, INC. (COVINGTON) -1018233 788426 NGFT1797 00801741015687

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other