BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD DEBAKEY DOUBLE VELOUR FABRIC

    MDR report key: 5051735 · Received September 2, 2015

    Report

    Report Number
    2020394-2015-01568
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    June 8, 2015
    Report Date
    July 3, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K770835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE LOT NUMBER WAS PROVIDED AND THE LOT DEVICE HISTORY RECORDS WERE REVIEWED. THE LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. VISUAL INSPECTION: SIX LOT SAMPLES WERE OPENED. ALL SAMPLES WERE CLEAN. THE EDGES OF THE FABRICS WERE INCONSISTENT TO THE OTHER EDGES CONFIRMING THE INVESTIGATION FOR FRAYED EDGES. THE SAMPLES WERE COMPARED TO THE VISUAL STANDARD IN PLACE AND DID NOT MEET THE STANDARD DISPLAYED IN THE PROCEDURE. THE WEAVE ALSO APPEARS INCONSISTENT ACROSS THE LENGTH OF THE SAMPLES. THE REMAINING FOUR SEALED SAMPLES WERE EVALUATED WITHIN THEIR PACKAGING. THE SAMPLES APPEARED CLEAN. THE EDGES OF THE FABRICS WERE NOTED TO BE INCONSISTENT ON ALL FOUR SAMPLES CONFIRMING THE INVESTIGATION FOR FRAYED EDGES. THE SAMPLES WERE COMPARED TO THE VISUAL STANDARD IN PLACE AND DID NOT MEET THE STANDARD DISPLAYED IN THE PROCEDURE. THE WEAVE ALSO APPEARS INCONSISTENT ACROSS THE LENGTH OF THE SAMPLES. FUNCTIONAL/PERFORMANCE EVALUATION: ONE SAMPLE WAS SHIPPED TO BARD (B)(4) FOR EVALUATION. THE END ITEM SPECIFICATIONS OF POROSITY AND SIZE WERE TESTED. THE SAMPLE WAS FOUND TO MEET ALL END ITEMS SPECIFICATIONS THAT WERE TESTED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED. IMAGE/PHOTO REVIEW: NO IMAGES OR PHOTOS WERE PROVIDED FOR EVALUATION. CONCLUSION: THE INVESTIGATION IS CONFIRMED FOR MATERIAL FRAYED, AS THE EDGES OF THE RETURNED SAMPLES WERE FOUND TO BE FRAYED. ADDITIONALLY THE INVESTIGATION IS CONFIRMED FOR NON-STANDARD DEVICE, AS THE FABRIC'S WEAVE APPEARED INCONSISTENT THROUGHOUT THE SAMPLE. A ROOT CAUSE OF THE FRAYED EDGES WAS FOUND TO ORIGINATE FROM DULL MACHINING BLADES. EQUIPMENT PREVENTIVE MAINTENANCE FREQUENCY AS WELL AS AN ADDITIONAL VISUAL INSPECTION WAS ESTABLISHED AT THE MANUFACTURING SITE AS A PREVENTATIVE MEASURE. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: CONTRAINDICATIONS: DUE TO THE HIGH PERMEABILITY OF THE KNITTED POLYESTER FABRICS, THEY ARE CONTRAINDICATED FOR USE IN PATIENTS REQUIRING PROLONGED SYSTEMIC OR HIGH DOSE HEPARINIZATION EXCEPT FOR USE IN REPAIR OF INTRACARDIAC DEFECTS. ADDITIONALLY, SPECIFIC WARNINGS, PRECAUTIONS AND DIRECTIONS FOR USE OF THE BARD DEBAKEY DOUBLE VELOUR FABRIC ARE INCLUDED IN THE CURRENT IFU.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. 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 THE FABRIC ALLEGEDLY APPEARS TO BE LARGE-MESHED AND THE QUALITY IS NOT THE SAME AS USUAL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582435 BARD DEBAKEY DOUBLE VELOUR FABRIC POLYESTER FABRIC DXZ BARD PERIPHERAL VASCULAR, INC. HUZC0779

    Patients

    Seq Age Sex Outcome Treatment
    1