BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD CLEAN-CATH INTERMITTENT CATHETER

    MDR report key: 10658754 · Received October 9, 2020

    Report

    Report Number
    1018233-2020-20023
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    September 17, 2020
    Report Date
    January 18, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741038877
    PMA / PMN Number
    K802665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE, AS NO SAMPLE RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO ¿TOO LITTLE COATING APPLIED TO THE CATHETER SURFACE." IT WAS UNKNOWN WHETHER THE DEVICE HAD MET SPECIFICATIONS. THE PRODUCT USED FOR THE TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS UNKNOWN, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. DO NOT USE IF PACKAGE IS DAMAGED. BARD AND CLEAN-CATH ARE TRADEMARKS AND /OR REGISTERED TRADEMARKS OF C.R. BARD, INC. OR AFFILIATE. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS." 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION. ALSO STATED THAT THE URINARY TRACT INFECTION WAS DUE TO THE INTERMITTENT CATHETERS WOULD NOT HAD ENOUGH LUBRICANT AND THE PATIENT PUSHED THE CATHETER WHICH WAS TOO DRY. THE PATIENT HAD STOPPED USING THE CATHETER FOR A WHILE AND THIS WAS HAPPENED 9 MONTHS AGO. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED FOR THE URINARY TRACT INFECTION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION. ALSO STATED THAT THE URINARY TRACT INFECTION WAS DUE TO THE INTERMITTENT CATHETERS WOULD NOT HAD ENOUGH LUBRICANT AND THE PATIENT PUSHED THE CATHETER WHICH WAS TOO DRY. THE PATIENT HAD STOPPED USING THE CATHETER FOR A WHILE AND THIS WAS HAPPENED 9 MONTHS AGO. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED FOR THE URINARY TRACT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122871 BARD CLEAN-CATH INTERMITTENT CATHETER COUDE INTERMITTENT CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 423714 UNK 00801741038877

    Patients

    Seq Age Sex Outcome Treatment
    1 Other