BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELANO VASCULAR Q2 EXTENSION SET

    MDR report key: 9312994 · Received November 12, 2019

    Report

    Report Number
    1649914-2019-00061
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 12, 2019
    Report Date
    November 12, 2019
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K182897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS MANUFACTURED AS BULK NON-STERILE AND SOLD TO AN OEM (VELANO VASCULAR) FOR FURTHER PROCESSING AND DISTRIBUTION. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. A DHR REVIEW WAS CONDUCTED AND NO ANOMALIES WERE SEEN. LEAK TESTING IS CONDUCTED AS PART OF THE MANUFACTURING PROCESS FOR THE DEVICE. THE ROOT CAUSE OF THE REPORTED COMPLAINT CONDITION IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING AN ALLEGED INCIDENT ENCOUNTERED DURING USE OF THE DEVICE. THE REPORT STATES THAT WHEN STARTING AN IV, THE DEVICE LEAKED AT THE EXTENSION TUBING JUNCTION / JOINT OFF THE TPORT. THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103636 VELANO VASCULAR Q2 EXTENSION SET IV EXTENSION SETS FPA QUEST MEDICAL, INC. 95906BNS 058115 OR 058116

    Patients

    Seq Age Sex Outcome Treatment
    1