BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

    MDR report key: 14487756 · Received May 24, 2022

    Report

    Report Number
    1018233-2022-04032
    Event Type
    Death
    Date Received
    May 24, 2022
    Date of Event
    May 5, 2022
    Report Date
    February 1, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    PMA / PMN Number
    K984084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION TO CONFIRM ANY DEVICE FAILURE, AND THE INFORMATION COLLECTED DURING THE INVESTIGATION WAS NOT CONCLUSIVE. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. IN CONCLUSION, AFTER REVIEW OF THE RISK MANAGEMENT FILE OF THE DEVICE INVOLVED IN THE EVENT IT WAS DETERMINED THAT THE MOST LIKELY POTENTIAL CAUSE OF THE EVENT IS "USER VIOLATION OF STANDARD PRACTICE" OR "USER OVERSIGHT, USER DID NOT FOLLOW PROCEDURE". HOWEVER THERE IS NO EVIDENCE TO CONFIRM IT AS THE DEFINITIVE CAUSE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "FOR UROLOGICAL USE ONLY" "VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE." 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 THE PATIENT EXPERIENCED A LACERATION DURING USE OF A FOLEY CATHETER. THE PATIENT ALSO HAD SEPTICEMIA AND PASSED AWAY AROUND ON (B)(6) 2022. CLINICAL FOLLOW UP INFORMATION WAS RECEIVED VIA EMAIL FROM THE REGIONAL COMPLAINT COORDINATOR (RCC) ON (B)(6) 2022. THE CATHETER WAS INSERTED BY A DISTRICT NURSE (DN) IN THE HOME SETTING, AND THERE WAS NOTHING ABNORMAL NOTED ABOUT THE DEVICE PRIOR TO INSERTION. THE DAY AFTER THE CATHETER WAS INSERTED, THE PATIENT¿S CARE GIVER WAS CLEANING HIM AND NOTICED A 3CM LONG OPEN LACERATION ON THE PATIENT¿S SCROTUM, BUT IT WAS UNKNOWN WHAT CAUSED THE WOUND. IT WAS NOTED THAT IT LOOKED LIKE THE CATHETER WAS INSERTED INTO THE SIDE WALL OF THE PENIS, BUT THIS COULD NOT BE CONFIRMED. THE PATIENT WAS SEEN BY HIS GENERAL PRACTITIONER (GP) TO ASSESS THE WOUND, AND CREAM WAS APPLIED. THE GP INFORMED THE PATIENT¿S BROTHER THAT THE WOUND WOULD LIKELY NOT CLEAR UP QUICKLY. THE PATIENT WAS LATER HOSPITALIZED FOR SEPTICEMIA, AND HE PASSED AWAY ON (B)(6) 2022. SEPTICEMIA WAS LISTED AS THE CAUSE OF DEATH ON THE DEATH CERTIFICATE. THE PATIENT¿S FAMILY MEMBER BELIEVED THIS WAS MORE OF A NURSE ISSUE RATHER THAN A CATHETER ISSUE. THE PATIENT DID NOT HAVE ANY RECENT SURGERIES OR PROCEDURES, AND THE ONLY MEDICAL HISTORY PROVIDED WAS DEMENTIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACERATION DURING USE OF A FOLEY CATHETER. THE PATIENT ALSO HAD SEPTICEMIA AND PASSED AWAY AROUND (B)(6) 2022. CLINICAL FOLLOW UP INFORMATION WAS RECEIVED VIA EMAIL FROM THE REGIONAL COMPLAINT COORDINATOR (RCC) ON (B)(6) 2022. THE CATHETER WAS INSERTED BY A DISTRICT NURSE (DN) IN THE HOME SETTING, AND THERE WAS NOTHING ABNORMAL NOTED ABOUT THE DEVICE PRIOR TO INSERTION. THE DAY AFTER THE CATHETER WAS INSERTED, THE PATIENT¿S CARE GIVER WAS CLEANING HIM AND NOTICED A 3CM LONG OPEN LACERATION ON THE PATIENT¿S SCROTUM, BUT IT WAS UNKNOWN WHAT CAUSED THE WOUND. IT WAS NOTED THAT IT LOOKED LIKE THE CATHETER WAS INSERTED INTO THE SIDE WALL OF THE PENIS, BUT THIS COULD NOT BE CONFIRMED. THE PATIENT WAS SEEN BY HIS GENERAL PRACTITIONER (GP) TO ASSESS THE WOUND, AND CREAM WAS APPLIED. THE GP INFORMED THE PATIENT¿S BROTHER THAT THE WOUND WOULD LIKELY NOT CLEAR UP QUICKLY. THE PATIENT WAS LATER HOSPITALIZED FOR SEPTICEMIA, AND HE PASSED AWAY ON (B)(6) 2022. SEPTICEMIA WAS LISTED AS THE CAUSE OF DEATH ON THE DEATH CERTIFICATE. THE PATIENT¿S FAMILY MEMBER BELIEVED THIS WAS MORE OF A NURSE ISSUE RATHER THAN A CATHETER ISSUE. THE PATIENT DID NOT HAVE ANY RECENT SURGERIES OR PROCEDURES, AND THE ONLY MEDICAL HISTORY PROVIDED WAS DEMENTIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207021 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER FOLEY CATHETER (SILICONE) EZL C.R. BARD, INC. (COVINGTON) -1018233 MYFW0023

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death| H