BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD DEBAKEY DOUBLE VELOUR FABRIC

    MDR report key: 5259720 · Received December 1, 2015

    Report

    Report Number
    2020394-2015-01951
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    November 2, 2015
    Report Date
    November 5, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    PMA / PMN Number
    K770235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Additional Manufacturer Narrative · 1

    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. THIS IS THE ONLY COMPLAINT REPORTED FOR THIS LOT NUMBER AND ISSUE TO DATE. VISUAL INSPECTION & FUNCTIONAL/PERFORMANCE EVALUATION: THE DEVICE WAS NOT RETURNED; THEREFORE, NO VISUAL INSPECTION OR FUNCTIONAL TESTING OF THE DEVICE WAS PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED FOR REVIEW. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE. AS ALL BARD DEBAKEY DOUBLE VELOUR FABRIC ARE 100% VISUALLY INSPECTED AT MANUFACTURING AND A SAMPLE IS TAKEN FROM THE LOT AND INSPECTED PRIOR TO FINAL RELEASE, IT IS UNLIKELY THAT THE ROOT CAUSE IS MANUFACTURING RELATED. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: THE CURRENT BARD DEBAKEY DOUBLE VELOUR FABRIC INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. 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 FIBERS OF THE SURGICAL FABRIC ALLEGEDLY BECAME LOOSE DURING SURGERY OF A VENTRICAL SEPTAL DEFECT. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBERS OF THE SURGICAL FABRIC ALLEGEDLY FRAYED DURING SURGERY OF A VENTRICLE SEPTAL DEFECT; HOWEVER, THE HEALTH CARE PROVIDER CHOSE TO CONTINUE WITH THE IMPLANTATION OF THE FABRIC. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788381 BARD DEBAKEY DOUBLE VELOUR FABRIC FABRIC DSY BARD PERIPHERAL VASCULAR, INC. HUZC0756

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR