BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYTE AUTOGUARD BL 22GA X 1.0IN

    MDR report key: 11787829 · Received May 6, 2021

    Report

    Report Number
    1710034-2021-00380
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K201075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOGUARD BL 22GA X 1.0IN CAP WAS DIFFICULT TO REMOVE AND CAUSED THE NURSE TO RECEIVE AN INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INSERTION OF A PERIPHERAL VENOUS LINE, THE NURSE ON DUTY FOUND HERSELF IN DIFFICULTY BECAUSE SHE WAS UNABLE TO REMOVE THE CAP FROM THE CATHETER. AFTER SEVERAL ATTEMPTS, SHE FINALLY MANAGED TO DO SO, BUT INJURED HER FINGER DURING THE REMOVAL MOVEMENT. IT SEEMS THAT THE NEEDLE OF THE CATHETER WAS BENT WHICH PREVENTED THE "UNBLOCKING". CLINICAL CONSEQUENCES: THE NURSE FOUND HERSELF WITH A FINGER PIERCED FROM ONE SIDE TO THE OTHER WITH THE NEED FOR SURGICAL MANAGEMENT AND A 15-DAY ABSENCE FROM WORK. UNFORTUNATELY, AS THE DEFECTIVE DEVICE WAS NOT KEPT, WE ARE AWARE THAT THE EXPERTISE CANNOT BE PERFORMED ON THE INCRIMINATED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680234 INSYTE AUTOGUARD BL 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381823 0216674 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention