BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARDEX 5CC LUBRICATH 2-WAY LATEX FOLEY CATHETER

    MDR report key: 5128536 · Received October 5, 2015

    Report

    Report Number
    1018233-2015-00373
    Event Type
    Death
    Date Received
    October 5, 2015
    Date of Event
    May 6, 2015
    Report Date
    November 19, 2015
    Manufacturer
    C.R. BARD, INC. (MONCKS) -1030583
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.

    Description of Event or Problem · 1

    BARD MEDICAL DIVISION FIELD ASSURANCE RECEIVED NOTIFICATION ON 9/10/2015 VIA FDA MEDWATCH REPORT THAT A PATIENT DEATH HAD OCCURRED. A HOSPITAL REPRESENTATIVE AT (B)(6) REPORTED THAT A BARDEX FOLEY CATHETER WAS ALLEGEDLY INSERTED TO A (B)(6) MALE PATIENT AND INITIALLY DRAINED 25ML OF URINE, BUT THEN STOPPED DRAINING. A BLADDER SCAN WAS PERFORMED AND ALLEGEDLY SHOWED THE PATIENT HAD 600ML OF URINE IN HIS BLADDER. THE NURSE ATTEMPTED TO DEFLATE THE BALLOON, BUT WAS UNSUCCESSFUL. A UROLOGIST WAS CONSULTED WHO ALLEGEDLY INSTILLED 3ML OF MINERAL OIL INTO THE BALLOON. AFTER SEVERAL MINUTES HAD ELAPSED, THE BALLOON RUPTURED AND THE CATHETER CAME OUT. THE UROLOGIST PLANNED TO PERFORM A CYSTOSCOPY AFTER THE PATIENT WAS STABILIZED TO DETERMINE IF ANY PIECES OF THE BALLOON REMAINED IN THE PATIENT, BUT THE PATIENT EXPIRED BEFORE THE PROCEDURE COULD BE PERFORMED. BARD MEDICAL DIVISION FIELD ASSURANCE REACHED OUT TO THE FACILITY ON 09/11/2015 TO GATHER ADDITIONAL INFORMATION. ACCORDING TO THE FACILITY, THE CATHETER WAS PLACED ON (B)(6) 2015 DUE TO URINARY OBSTRUCTION (PREVIOUS PROSTATECTOMY) AND WAS DEFLATED/REMOVED SAME DAY. AN UNKNOWN AMOUNT OF SALINE WAS USED TO INFLATE THE TUBE AND IT IS UNKNOWN WHAT TYPE OF LUBRICANT WAS USED ON THE CATHETER. THERE WAS NOT ANY IRRIGATION BEING PERFORMED. THE CATHETER WAS NOT BEING USED FOR HEMOSTASIS OR BLADDER DRAINAGE AND THERE WAS NO TRACTION APPLIED OR SUTURES USED TO ANCHOR THE CATHETER. ANOTHER CATHETER WAS PLACED AND NO ADDITIONAL INTERVENTION WAS PERFORMED. IT IS UNKNOWN IF THERE WERE ANY MISSING PIECES FROM THE BALLOON. THE UROLOGIST HAD PLANNED ON DOING A CYSTOSCOPY AFTER THE PATIENT STABILIZED FROM HIS UNDERLYING CARDIAC CONDITION; HOWEVER, THE PATIENT EXPIRED ON (B)(6) 2015 PRIOR TO THE PROCEDURE BEING PERFORMED DUE TO SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658859 BARDEX 5CC LUBRICATH 2-WAY LATEX FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD, INC. (MONCKS) -1030583 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death