BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SHUNT

    MDR report key: 8805210 · Received July 18, 2019

    Report

    Report Number
    2020394-2019-01604
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DWF
    UDI-DI
    00801741090219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT FOR MATERIAL EROSION IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE 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

    THIS REPORT SUMMARIZES ONE MALFUNCTION . A REVIEW OF THE EVENT INDICATED THAT MODEL SGA15001 VASCULAR, CARDIOPULMONARY BYPASS SHUNT ALLEGED THAT THE PAINT ON THE SHUNT CAME OFF, AND WAS LEFT INSIDE OF THE PATIENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENTS AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT FOR MATERIAL EROSION IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION . A REVIEW OF THE EVENT INDICATED THAT MODEL SGA15001 VASCULAR, CARDIOPULMONARY BYPASS SHUNT ALLEGED THAT THE PAINT ON THE SHUNT CAME OFF, AND WAS LEFT INSIDE OF THE PATIENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENTS AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596456 SURGICAL SHUNT CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF BARD PERIPHERAL VASCULAR, INC. SGA150001 HUCX0313 00801741090219

    Patients

    Seq Age Sex Outcome Treatment
    1