BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAGUIDE® URETERAL ACCESS SHEATH

    MDR report key: 17349309 · Received July 19, 2023

    Report

    Report Number
    1018233-2023-05268
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 26, 2023
    Report Date
    October 19, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FED
    UDI-DI
    00801741052569
    PMA / PMN Number
    K033778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. H11: SECTION A THROUGH F - 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. ALTHOUGH AN EXACT ROOT CAUSE COULD NOT BE DETERMINED A POTENTIAL ROOT CAUSE COULD BE MATERIAL SELECTION/ PART GEOMETRY OF LUER. A DHR REVIEW IS NOT REQUIRED AS NO LOT NUMBER WAS REPORTED FOR THIS INVESTIGATION. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "DIRECTIONS FOR USE: ONLY PHYSICIANS TRAINED IN USE OF ENDOSCOPIC EQUIPMENT SHOULD USE THIS DEVICE. A VARIETY OF TECHNIQUES MAY BE EMPLOYED; HOWEVER, THE PHYSICIAN SHOULD USE THE TECHNIQUE MOST APPROPRIATE FOR THE INDIVIDUAL PATIENT¿S SITUATION." 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 IN AN ONLINE SURVEY A PHYSICIAN STATED NO TO THE QUESTION WHEN THEY WERE ASKED IF THEY WERE ABLE TO SUCCESSFULLY INJECT FLUIDS. THE PHYSICIAN WAS NOT ABLE TO SUCCESSFULLY INJECT FLUIDS BECAUSE UNKNOWN IN RELATION TO 131135 ¿ AQUAGUIDE URETERAL ACCESS SHEATH ¿DILATOR 10FR/SHEATH DIAMETER 12/14FR, LENGTH 35CM.

    Description of Event or Problem · 0

    CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT NO TO THE QUESTION WHEN THEY WERE ASKED IF THEY WERE ABLE TO SUCCESSFULLY INJECT FLUIDS. THE PHYSICIAN WAS NOT ABLE TO SUCCESSFULLY INJECT FLUIDS BECAUSE UNKNOWN IN RELATION TO 131135 - AQUAGUIDE® URETERAL ACCESS SHEATH ¿DILATOR 10FR/SHEATH DIAMETER 12/14FR, LENGTH 35CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734924 AQUAGUIDE® URETERAL ACCESS SHEATH URETERAL ACCESS SHEATH FED C.R. BARD, INC. (COVINGTON) -1018233 131135 UNK 00801741052569

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other