BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATEX FOLEY CATHETER

    MDR report key: 11509377 · Received March 17, 2021

    Report

    Report Number
    1018233-2021-01348
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 23, 2021
    Report Date
    June 7, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿MISSING INSTRUCTIONS¿. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. UNABLE TO PERFORM LABELLING REVIEW DUE TO UNKNOWN PRODUCT CODE. ALTHOUGH THE PRODUCT FAMILY WAS UNKNOWN, THE LATEX FOLEY CATHETER PRODUCT IFUS WERE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABELING OF THE CATHETERS ONLY HAD ¿NRL¿ WITH A LINE STRIKEOUT FOR SILICONE, BUT THERE WERE NO LARGE/BOLD VISUALS FOR LATEX FOLEY AND ALSO MENTIONED THAT WOULD BE GOOD IF THE LABELING MAKE THINGS EASIER TO VISUALIZE THOSE CATHETERS THAT CONTAIN LATEX. FOR NOW THERE WERE NO REACTIONS TO THE PATIENTS WITH THE ALLERGIES TO LATEX.

    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 BD 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 BD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABELING OF THE CATHETERS ONLY HAD ¿NRL¿ WITH A LINE STRIKEOUT FOR SILICONE, BUT NOTHING LARGE/BOLD FOR LATEX FOLEY AND ALSO MENTIONED THAT WILL BE GOOD IF THE LABELING MAKE THINGS EASIER TO VISUALIZE THOSE CATHETERS THAT CONTAIN LATEX. FOR NOW THERE WERE NO REACTIONS TO THE PATIENTS WITH THE ALLERGIES TO LATEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405106 LATEX FOLEY CATHETER UNKNOWN FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other