BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX MALECOT MODEL DRAIN

    MDR report key: 10600515 · Received September 29, 2020

    Report

    Report Number
    1018233-2020-06242
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 4, 2020
    Report Date
    January 21, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FEW
    UDI-DI
    00801741023835
    PMA / PMN Number
    K070879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED SINCE THE PRODUCT MEETS SPECIFICATIONS. THREE UNOPENED MALECOTS WERE RETURNED IN THEIR ORIGINAL PACKAGING ALL THREE MALECOTS WERE MEASURED AND WERE FOUND TO BE 14 FRENCH MEET SPECIFICATIONS. AS THE FRENCH SIZE WAS FOUND TO BE 14 FRENCH FOR ALL THREE CATHETERS, THERE DOES NOT APPEAR TO BE A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE. THE DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT WAS UNCONFIRMED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT CONTAINED THE DEVICE OF DIFFERENT HARDNESS. IT WAS ALSO STATED THAT THE WRONG SIZE WAS INCORRECTLY PACKED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT CONTAINED THE DEVICE OF DIFFERENT HARDNESS. IT WAS ALSO STATED THAT THE WRONG SIZE WAS INCORRECTLY PACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068099 BARDEX MALECOT MODEL DRAIN MALECOT FEW C.R. BARD, INC. (COVINGTON) -1018233 086014 NGDX4162 00801741023835

    Patients

    Seq Age Sex Outcome Treatment
    1