BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIA® FOLEY CATHETER SILICONE COATED

    MDR report key: 19380631 · Received May 23, 2024

    Report

    Report Number
    1018233-2024-02901
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    May 3, 2024
    Report Date
    June 19, 2024
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741095207
    PMA / PMN Number
    K922431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED . IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE USER RELATED (EXAMPLE: OVER ASPIRATED, INCORRECT SYRINGE/COLLAPSE LUMEN/SAC CLOSE EYE/VALVE DAMAGE). A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE, THIN RUBBERIZE WALL THAT CAUSING COLLAPSE/PINCH INFLATION LUMEN UNDER THE BALLOON OR ALONG THE SHAFT .A DHR REVIEW IS NOT REQUIRED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE BALLOON BURST. DO NOT ASPIRATE URINE THROUGH THE DRAINAGE FUNNEL WALL. SINGLE PATIENT USE ONLY. DO NOT REUSE AND RESTERILIZE. FOR UROLOGICAL USE ONLY. USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN. IF PERMITTED BY HOSPITAL PROTOCOL, THE MAY BE CUT OFF. IF THIS FAILS, CONTACT AN ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT." 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 THEY HAD 3 INSTANCES OVER THE PAST COUPLE OF WEEKS WITH CATHETERS THAT SEEM TO HAVE A FAULTY BALLOON. 2 OF THESE PATIENTS HAVE HAD TO GO TO THE ER TO HAVE THE CATHETER REMOVED AND THE PHYSICIANS IN THE ER WERE ALSO UNABLE TO DEFLATE THE BALLOON. ONE OF THEM HAD TO HAVE A PROCEDURE TO REMOVE IT AND THE OTHER THEY WERE ABLE TO CUT THE CATHETER AND EVENTUALLY THE BALLOON DEFLATED. THE ER PHYSICIAN STATED THAT THEY WERE PERPLEXED AS TO WHY THE BALLOON WOULD NOT DEFLATE. THE 3RD PATIENT WAS GOING TO THE ER TODAY AS HIS WAS STILL DRAINING AND THEY DID NOT WANT TO GO LAST NIGHT. 2 OF THESE CATHETERS ARE THE SAME BRAND AND ITEM NUMBER ¿ BARD 18FR 802318. THEY WERE UNABLE TO FIND A LOT NUMBER IN MCKESSON TO SEE IF THEY WERE THE SAME. THE 3RD PATIENT ALSO HAD A BARD 20 FRENCH WITH 30CC BALLOON 802320. THEY WERE CONCERNED THAT THERE MAY BE A FAULTY LOT NUMBER. THEY DID NOT WANT PATIENTS HAVING TO GO TO THE ER AND HAVE PROCEDURES THAT ARE UNNECESSARY WHEN THEY ARE ALREADY EXPERIENCING HEALTH ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY HAD 3 INSTANCES OVER THE PAST COUPLE OF WEEKS WITH CATHETERS THAT SEEM TO HAVE A FAULTY BALLOON. 2 OF THESE PATIENTS HAVE HAD TO GO TO THE ER TO HAVE THE CATHETER REMOVED AND THE PHYSICIANS IN THE ER WERE ALSO UNABLE TO DEFLATE THE BALLOON. ONE OF THEM HAD TO HAVE A PROCEDURE TO REMOVE IT AND THE OTHER THEY WERE ABLE TO CUT THE CATHETER AND EVENTUALLY THE BALLOON DEFLATED. THE ER PHYSICIAN STATED THAT THEY WERE PERPLEXED AS TO WHY THE BALLOON WOULD NOT DEFLATE. THE 3RD PATIENT WAS GOING TO THE ER TODAY AS HIS WAS STILL DRAINING AND THEY DID NOT WANT TO GO LAST NIGHT. 2 OF THESE CATHETERS ARE THE SAME BRAND AND ITEM NUMBER ¿ BARD 18FR 802318. THEY WERE UNABLE TO FIND A LOT NUMBER IN MCKESSON TO SEE IF THEY WERE THE SAME. THE 3RD PATIENT ALSO HAD A BARD 20 FRENCH WITH 30CC BALLOON 802320. THEY WERE CONCERNED THAT THERE MAY BE A FAULTY LOT NUMBER. THEY DID NOT WANT PATIENTS HAVING TO GO TO THE ER AND HAVE PROCEDURES THAT ARE UNNECESSARY WHEN THEY ARE ALREADY EXPERIENCING HEALTH ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788319 BARDIA® FOLEY CATHETER SILICONE COATED FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741095207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention