BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOSORB FAST

    MDR report key: 12316827 · Received August 12, 2021

    Report

    Report Number
    3006981798-2021-00008
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 30, 2020
    Report Date
    August 12, 2021
    Manufacturer
    RIVERPOINT MEDICAL
    Product Code
    GAM
    UDI-DI
    20884521149370
    PMA / PMN Number
    K120556
    Removal / Correction Number
    Z-0015-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VELOSORB PRODUCT WERE LABELED AS NON-STERILE AND INTENDED FOR SHIPMENT TO THE CONTRACT STERILIZER BUT WERE INADVERTENTLY SHIPPED TO THE DISTRIBUTOR. RIVERPOINT PLACED AN IMMEDIATE HOLD ON MANUFACTURING AND DISTRIBUTION OF THE VELOSORB PRODUCT AND A DEVICE RECALL (Z0015-2021). CORRECTIVE ACTIONS WERE TAKEN BY RIVERPOINT TO PREVENT INCORRECT SHIPPING OF NON-STERILE PRODUCT. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL, OR ITS EMPLOYEES, THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR PART 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    VELOSORB PRODUCTS WERE LABELED AS NON-STERILE AND INTENDED FOR SHIPMENT TO THE CONTRACT STERILIZER BUT WERE INADVERTENTLY SHIPPED TO THE DISTRIBUTOR. PRODUCTS WERE FURTHER DISTRIBUTED TO CUSTOMERS. RIVERPOINT PLACED AN IMMEDIATE HOLD ON MANUFACTURING AND DISTRIBUTION OF THE VELOSORB PRODUCT AND DEVICE RECALL Z-0015-2021 WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213265 VELOSORB FAST SUTURE GAM RIVERPOINT MEDICAL CV-417G 20051406X 20884521149370

    Patients

    Seq Age Sex Outcome Treatment
    1