BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

    MDR report key: 22905099 · Received August 27, 2025

    Report

    Report Number
    1018233-2025-07161
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 8, 2025
    Report Date
    October 27, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741034152
    PMA / PMN Number
    K984084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATES: "VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE.". A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. CORRECTIONS: D, E, F, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 ONE ISSUE ON (B)(6) 2025 WITH THE BAG NOT DRAINING, PRODUCT CONCERN FORM WAS SUBMITTED, AND THE SECOND INCIDENT OF THE BAG NOT DRAINING OCCURRED OVERNIGHT, PRODUCT CONCERN FORM WAS SUBMITTED THAT MORNING. THEY HAD AN ADDITIONAL ISSUE OF A FOLEY BAG LEAKING THEY DID NOT THINK A PRODUCT CONCERN FORM WAS SUBMITTED. THEY TOLD BY LABOR AND DELIVERY THAT WITHIN THE LAST 2 DAYS THEY ALSO ENCOUNTERED A FOLEY BAG THAT WAS NOT DRAINING, THEY DID NOT KNOW IF A CONCERN FORM WAS SUBMITTED. IN LOOKED AT THE LIST OF 17 CONCERNS THERE WERE MANY SIMILAR CONCERNS WITH THE FOLEY BAG OR THE BALLOON LEAKING. THAT ALSO APPEARED THAT THE MAJORITY OF OUR CONCERNS WERE FROM 2 DIFFERENT GROUPS OF FOLEYS IN MULTIPLE SIZES WITHIN THE GROUP. GROUP 1: (B)(4) FOR SIZE FOR FOLEY BAG (MATERIAL# 154002) AND FOR CATHETER (MATERIAL# 175814). GROUP 2: (B)(4) FOR SIZE FOR DRAIN BAG (MATERIAL# Z10) AND FOR CATHETER (MATERIAL# Z01). LABOR AND DELIVERY PULLED ABOUT 25 OF THE FOLEY TRAYS WITH LOT # NGKP4405 AND THEY HAD PULLED 3 FROM THE MBU STOCK. HRPS AND PRODUCT CONCERN FORM ((B)(4)) WERE COMPLETED. THE TWO USED, DEFECTIVE FOLEYS WERE SAVED AND AVAILABLE TO BE PICKED UP. THEY WERE ALL IN KALEYA OFFICE, THEY CAN HELP SOMEONE TO RETRIEVE THEM IF NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY HAD ONE ISSUE ON 22JUL2025 WITH THE BAG NOT DRAINING, PRODUCT CONCERN FORM WAS SUBMITTED, AND THE SECOND INCIDENT OF THE BAG NOT DRAINING OCCURRED OVERNIGHT, PRODUCT CONCERN FORM WAS SUBMITTED THAT MORNING. THEY HAD AN ADDITIONAL ISSUE OF A FOLEY BAG LEAKING THEY DID NOT THINK A PRODUCT CONCERN FORM WAS SUBMITTED. THEY TOLD BY LABOR AND DELIVERY THAT WITHIN THE LAST 2 DAYS THEY ALSO ENCOUNTERED A FOLEY BAG THAT WAS NOT DRAINING, THEY DID NOT KNOW IF A CONCERN FORM WAS SUBMITTED. IN LOOKED AT THE LIST OF 17 CONCERNS THERE WERE MANY SIMILAR CONCERNS WITH THE FOLEY BAG OR THE BALLOON LEAKING. THAT ALSO APPEARED THAT THE MAJORITY OF OUR CONCERNS WERE FROM 2 DIFFERENT GROUPS OF FOLEYS IN MULTIPLE SIZES WITHIN THE GROUP. GROUP 1: A947314 FOR SIZE FOR FOLEY BAG (MATERIAL#154002) AND FOR CATHETER (MATERIAL#175814). GROUP 2: A3195 FOR SIZE FOR DRAIN BAG (MATERIAL#Z10) AND FOR CATHETER (MATERIAL#Z01). LABOR AND DELIVERY PULLED ABOUT 25 OF THE FOLEY TRAYS WITH LOT #NGKP4405 AND THEY HAD PULLED 3 FROM THE MBU STOCK. HRPS AND PRODUCT CONCERN FORM (4616-PC) WERE COMPLETED. THE TWO USED, DEFECTIVE FOLEYS WERE SAVED AND AVAILABLE TO BE PICKED UP. THEY WERE ALL IN KALEYA OFFICE, THEY CAN HELP SOMEONE TO RETRIEVE THEM IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380092 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER SILICONE FOLEY CATHETER EZL C.R. BARD INC. (COVINGTON) -1018233 NGKP4405 00801741034152

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other