BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER

    MDR report key: 19772923 · Received July 18, 2024

    Report

    Report Number
    1018233-2024-04315
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 29, 2024
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    MJC
    PMA / PMN Number
    K984136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS CONFIRMED- CAUSE UNKNOWN. PHOTO: RECEIVED FOUR (4) PHOTO SAMPLES. ALL PHOTO SAMPLES SHOWCASE AN OVERVIEW OF A 2-WAY FOLEY CATHETER WITH CUT PORTION OF INLET TUBING AND ITS PACKAGING. VISUAL: RECEIVED ONE (1) USED 2-WAY FOLEY CATHETER WITH CUT PORTION OF INLET TUBING WITHOUT ORIGINAL PACKAGING, VISUAL INSPECTION NOTED BALLOON RUPTURE (MEASURING 0.3820) ON THE RETURN SAMPLE. NO MISSING PIECES WERE NOTED. THIS IS OUT OF SPECIFICATION WHICH STATES, "BALLOON MUST NOT BE TORN. ROOT CAUSE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE PINHOLE IN BALLOON OR CUFF. 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: WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLATUM BASE. THEY WILL DAMAGE SILICONE AND MAY CAUSE THE BALLOON TO BURST. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL STATE, AND FEDERAL LAWS AND REGULATIONS. CAUTIONS: FEDERAL (U.S.A) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. CAUTIONS: DO NOT ASPIRATE URINE THROUGH DRAINAGE FUNNEL WALL. STORAGE: STORE CATHETER AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. NOTE: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR 100 PERCENTAGE SILICONE FOLEY CATHETERS. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. CATHETERS SHOULD BE REPLACED IN ACCORDANCE WITH THE CDC GUIDELINE GUIDELINE FOR PREVENTION OF CATHETER-ASSOCIATED URINARY TRACT INFECTION. AT THE ONSET OR FIRST SIGNS OF A URINARY TRACT INFECTION, CATHETER ENCRUSTATION, OR ANY OTHER CATHETER-RELATED ADVERSE EFFECT, THE CATHETER SHOULD BE REPLACED. 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. ALLOW THE BALLOON TO DEFLATE SLOWLY ON ITS OWN. DO NOT ASPIRATE OR MANUALLY ACCELERATE THE DEFLATION OF THE BALLOON. IF PERMITTED BY HOSPITAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. IF THIS FAILS, CONTACT 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. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. RECOMMENDED INFLATION CAPACITIES. 5CC BALLOON: USE 10CC STERILE WATER 30CC BALLOON: USE 35CC STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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 SPONTANEOUS REMOVAL OF THE FOLEY CATHETER BALLOON AFTER FEW MINUTES OF PREOPERATIVE INSERTION IN THE OPERATION ROOM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SPONTANEOUS REMOVAL OF THE FOLEY CATHETER BALLOON AFTER FEW MINUTES OF PREOPERATIVE INSERTION IN THE OPERATION ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032811 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER FOLEY CATHETER MJC C.R. BARD INC. (COVINGTON) -1018233 NGHT2237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other