BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® MALECOT MODEL DRAIN

    MDR report key: 6957613 · Received October 18, 2017

    Report

    Report Number
    1018233-2017-05328
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 22, 2017
    Report Date
    December 28, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FEW
    UDI-DI
    00801741023910
    PMA / PMN Number
    K070879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED 1 UNOPENED URETHRAL CATHETER. THE REPORTED ISSUE WAS CONFIRMED SINCE FOREIGN LOOSE MATERIAL WAS FOUND INSIDE THE PACKAGE. DURING THE VISUAL EVALUATION, IT WAS NOTED THAT LOOSE FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE THAT EXCEEDED THE SPECIFICATION. THE SAMPLE WAS RECEIVED WITH THE PACKAGE CLOSED. THE REPORTED EVENT WAS CONFIRMED AS MANUFACTURING RELATED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "INDICATIONS FOR USE: 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. CAUTION: CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS. STERILIZED BY ETHYLENE OXIDE DO NOT USE IF PACKAGE IS DAMAGED. SINGLE USE ONLY DO NOT RESTERILIZE. CAUTION, CONSULT ACCOMPANYING DOCUMENTS." (B)(4).

    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

    IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE PACKAGE PRIOR TO OPEN IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE PACKAGE PRIOR TO OPEN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738481 BARDEX® MALECOT MODEL DRAIN MALECOT FEW C.R. BARD, INC. (COVINGTON) -1018233 086030 NGAY2891 00801741023910

    Patients

    Seq Age Sex Outcome Treatment
    1