BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX MALECOT MODEL DRAIN

    MDR report key: 10134823 · Received June 9, 2020

    Report

    Report Number
    1018233-2020-03702
    Event Type
    Injury
    Date Received
    June 9, 2020
    Date of Event
    August 1, 2019
    Report Date
    August 24, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FEW
    PMA / PMN Number
    K070879
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED, AS A USE-RELATED. THE DEVICE APPEARED TO BE INSERTED INCORRECTLY AND USED OUTSIDE ITS INTENDED USE. THE ROOT CAUSE FOR THIS FAILURE MODE WAS DUE TO THE USER WAS NOT FAMILIAR WITH THE DEVICE OR THE APPROPRIATE PROCEDURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS UNKNOWN, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. FOR UROLOGICAL USE ONLY. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIECE OF THE MALECOT CATHETER MIGRATED FROM THE RECTUM TO THE BLADDER. THIS WAS DETECTED BY AN ULTRASOUND. IT WAS NOTED THAT THE PHYSICIAN PURPOSELY CUT THE CATHETER PER ADDITIONAL INFORMATION RECEIVED 02JUN2020 VIA EMAIL, THE DEVICE WAS PLACED BY THE GENERAL SURGEON TO DRAIN THE PERITONEAL SPACE AND HOW IT WAS MIGRATED TO THE BLADDER WAS UNKNOWN. THE USE OF THE DEVICE WAS REPORTED AS COMMON PRACTICE AT THE HOSPITAL. THE CATHETER IS FOR UROLOGICAL USE ONLY. IT WAS CUT AND LEFT INSIDE THE PATIENT. THE COMPLAINANT INDICATED THE PATIENT HEALTH OUTCOME WAS GOOD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE MALECOT CATHETER MIGRATED FROM THE RECTUM TO THE BLADDER. THIS WAS DETECTED BY AN ULTRASOUND. IT WAS NOTED THAT THE PHYSICIAN PURPOSELY CUT THE CATHETER AND WAS PLACED BY THE GENERAL SURGEON TO DRAIN THE PERITONEAL SPACE AND HOW IT WAS MIGRATED TO THE BLADDER WAS UNKNOWN. THE USE OF THE DEVICE WAS REPORTED AS COMMON PRACTICE AT THE HOSPITAL CATHETER IS FOR UROLOGICAL USE ONLY. IT WAS CUT AND LEFT INSIDE THE PATIENT. THE COMPLAINANT INDICATED THE PATIENT HEALTH OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598368 BARDEX MALECOT MODEL DRAIN MALECOT CATHETER FEW C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other