BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARDIA CATHETER FOLEY 3 WAY 22F 30ML

    MDR report key: 2401096 · Received January 4, 2012

    Report

    Report Number
    1018233-2011-00501
    Event Type
    Death
    Date Received
    January 4, 2012
    Date of Event
    November 5, 2011
    Report Date
    December 6, 2011
    Manufacturer
    BARD SDN. BHD.
    Product Code
    FTL
    PMA / PMN Number
    K910846
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. NO LOT NUMBER WAS PROVIDED BY THE HOSPITAL FOR THE ACTUAL FOLEY INVOLVED IN THE ALLEGED EVENT. HOWEVER, THE HOSPITAL DID NOT PROVIDE THE CURRENT FOLEY LOT #, MYTHR436, OF THE PRODUCT AVAILABLE AT THE TIME OF THIS REPORT. THE DHR FOR FOLEY LOT # MYTHR436 WAS REVIEWED. CATHETERS WERE VERIFIED FOR PROPER INFLATION AND DEFLATION DURING IN-PROCESS AND FINAL INSPECTION. THERE WERE NO DEFECTS NOTED IN THE LOT HISTORY WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A LABELING REVIEW WAS CONDUCTED. THE PRODUCT LABELING STATES: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY BURST BALLOON. INFLATE WITH 35ML OF STERILE WATER. FOR UROLOGICAL USE ONLY. THE FOLEY CATHETER WAS USED OFF-LABEL BY THE DOCTOR AT THE HOSPITAL. THE PRODUCT IS INDICATED FOR USE FOR THE "EXPORT OF URINE FROM THE BLADDER" IN THE REGISTRATION CERTIFICATE FOR (B)(4). THIS IS THE FIRST REPORTED INCIDENT OF THIS KIND. THIS PRODUCT CATALOG IS SOLD EXCLUSIVELY OUTSIDE OF THE UNITED STATES. THE 510 (K) NUMBER REFERENCED IN THIS MDR SECTION G IS FOR A SIMILAR PRODUCT SOLD AND DISTRIBUTED IN THE UNITED STATES. BASED ON THE EVENT DESCRIPTION, THERE WERE TWO FOLEY'S USED DURING THE PROCEDURE, A SECOND MDR WAS FILED FOR THE SECOND INCIDENT, REFER TO #1018233-2011-00502. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT REC'D RESECTION OF THE PROSTATE AT (B)(6) HOSPITAL ON (B)(6) 2011. DURING THE PROCEDURE, THE FOLEY CATHETER WAS USED FOR HEMOSTASIS BY COMPRESSION WHICH RESULTED IN THE RUPTURE OF FIRST AND SECOND FOLEY CATHETER. THE DOCTOR USED ANOTHER COMPANY'S CATHETER TO ACHIEVE COMPRESSION HEMOSTASIS. THE PT DIED OF SHOCK DUE TO BLEEDING ON NOVEMBER 5, 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDIA CATHETER FOLEY 3 WAY 22F 30ML FTL BARD SDN. BHD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death