BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 12096612 · Received June 30, 2021

    Report

    Report Number
    9616066-2021-51431
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    April 20, 2021
    Report Date
    September 30, 2021
    Product Code
    FPA
    UDI-DI
    50885403233904
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-07-02 . H6: INVESTIGATION SUMMARY THE CUSTOMER REPORTED THE TUBE DETACHED FROM THE SENSOR DISC, AND RETURNED ONE USED SAMPLE. THE SAMPLE WAS CLEARLY SEPARATED AT THE SENSOR DISC, AND THE COMPLAINT IS VERIFIED. THE ROOT CAUSE WAS THOUGHT TO BE TUBING DIAMETER, AND WAS SENT TO MANUFACTURING LOCATION FOR FURTHER INVESTIGATION. THE INVESTIGATION THERE FOUND THE TUBING TO BE WITHIN TOLERANCE. THE ROOT CAUSE IS INCONSISTENT OR WRONG USE OF THE MEDICA SOLVENT APPLICATOR. A CORRECTIVE ACTION WAS IMPLEMENTED TO BALANCE THE OPERATIONS ON THE MANUFACTURING CELL, WHICH IS INTENDED TO ELIMINATE THE FAILURE MODE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 10014914 BECAUSE A VALID LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AS SYR PSD MICROBORE TUBING DETACHED FROM THE SENSOR DISK DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBE DETACHED FROM SENSOR DISK"

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AS SYR PSD MICROBORE TUBING DETACHED FROM THE SENSOR DISK DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBE DETACHED FROM SENSOR DISK"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989540 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA 10014914 UNKNOWN 50885403233904

    Patients

    Seq Age Sex Outcome Treatment
    1