BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC YEL 24GA X 0.75IN

    MDR report key: 11340428 · Received February 17, 2021

    Report

    Report Number
    1710034-2021-00117
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    December 11, 2020
    Report Date
    February 5, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825127
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (B)(6) 2020. MEDWATCH REPORT # (B)(4). REPORT SOURCE OTHER: MEDWATCH REPORT (B)(4). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. RATIONALE: CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS, HOWEVER THE NEED FOR A FORMAL CORRECTIVE ACTION CANNOT BE DETERMINED IN THE ABSENCE OF THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOG BC YEL 24GA X 0.75IN NEEDLE WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382512, BATCH NO.: 9190483. IT WAS REPORTED THAT THE DEVICE COULD NOT BE INSERTED INTO PATIENT'S SKIN DUE TO DEVICE BEING WIGGLY AND LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236821 INSYTE AUTOG BC YEL 24GA X 0.75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9190483 00382903825127

    Patients

    Seq Age Sex Outcome Treatment
    1