BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® FOLEY CATHETER SILICONE COATED

    MDR report key: 19990099 · Received August 15, 2024

    Report

    Report Number
    1018233-2024-04943
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 22, 2024
    Report Date
    July 30, 2024
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741095207
    PMA / PMN Number
    K922431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE PRODUCT WAS USED FOR UROLOGICAL CARE. 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 REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: STRUCTURE AND COMPOSITION: THE PRODUCT INCLUDE THREE SERIES: BARDEX, BARDIC AND BARDIA. THE COMPOSITION OF EACH SERIES IS AS FOLLOWS: BARDEX, BARDIC AND BARDIA BI-LUMEN SERIES ARE COMPOSED OF CATHETER BODY, INFLATION CONE INTERFACE, BALLOON AND VALVE. BARDIA TRI-LUMEN IS COMPOSED TO TUBE BODY, INFLATION CONE INTERFACE, DEFLATION CONE INTERFACE, FLUSH CONE INTERFACE, BALLOON AND VALVE. THE PRODUCT IS WITH SILICONE COATING. THE MATERIAL OF CATHETER BODY, INFLATION CONICAL INTERFACE, DEFLATION CONICAL INTERFACE, FLUSHING CONICAL INTERFACE, BALLOON IS NATURAL LATEX. THE MATERIAL OF VALVE IS POLYPROPYLENE. STERILIZED BY GAMMA RADIATION. DISPOSABLE. SCOPE OF APPLICATION: FOLEY CATHETER IS INTENDED FOR USE IN THE DRAINAGE OF URINE FROM THE BLADDER OF CHILDREN AND ADULTS. PRECAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION. STERILE UNLESS PACKAGE HAS BEEN OPENED OR DAMAGE. WARNING: DO NOT USE PETROLEUM SUBSTRATE LUBRICANTS WITH THE LATEX- BASED URETHRAL CATHETERS SUCH AS PETROLEUM JELLY AND LABEL LIQUID PARAFFIN, WHICH WILL DAMAGE LATEX AND MAY BURST BALLOON. WATER-SOLUBLE LUBRICANT CAN BE USED. VALVE TYPE: USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. TO DEFLATE CATHETER BALLOON: GENTLE INSERT A SYRINGE IN THE CATHETER VALVE. NEVER USE EXCESSIVE FORCE 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 PRACTICAL, THE VALVE MAY BE CUT OFF. IF THIS FAILS, PLEASE CONTACT AN ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PRACTICAL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. STORAGE: CATHETERS NEED TO BE STORED AT ROOM TEMPERATURE AND KEEP AWAY FROM THE DIRECT LIGHT AND PREFERABLY STORED IN THE ORIGINAL PACKING BOX. DO NOT USE THE PRODUCT OF HAVE LATEX ALLERGY. THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. 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 AFTER THE OPERATION FOR A HIGH-LEVEL PARAPLEGIC PATIENT, THE FOLEY CATHETER BALLOON WAS BLOCKED, AND THE CATHETER COULD NOT BE REMOVED. PATIENT EXPERIENCED URETHRAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895095 BARDIA® FOLEY CATHETER SILICONE COATED FOLEY CATHETER KOD C.R. BARD INC. (COVINGTON) -1018233 MYGZ4107 00801741095207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other