BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16"

    MDR report key: 17799513 · Received September 22, 2023

    Report

    Report Number
    1710034-2023-01093
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 5, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814343
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" THE NEEDLE WOULD NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY WE HAD A 3RD SIMILAR INCIDENT. AGAIN, THE USER PRESSED THE RETRACTION BUTTON BUT THE NEEDLE DID NOT RETRACT. THE STAFF MEMBER REPORTED SHE PRESSED THE BUTTON SEVERAL TIMES AND WITH SOME FORCE BUT THE NEEDLE DID NOT RETRACT. THIS HAPPENED 9/6/2023. LOT 3192264 EXP 6/30/2026. THERE IS NO PHOTOGRAPH AND THE PHYSICAL DEVICE WAS DISCARDED. THERE WAS NO INJURY OR OTHER ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" THE NEEDLE WOULD NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY WE HAD A 3RD SIMILAR INCIDENT. AGAIN, THE USER PRESSED THE RETRACTION BUTTON BUT THE NEEDLE DID NOT RETRACT. THE STAFF MEMBER REPORTED SHE PRESSED THE BUTTON SEVERAL TIMES AND WITH SOME FORCE BUT THE NEEDLE DID NOT RETRACT. THIS HAPPENED 9/6/2023. LOT 3192264 EXP 6/30/2026. THERE IS NO PHOTOGRAPH AND THE PHYSICAL DEVICE WAS DISCARDED. THERE WAS NO INJURY OR OTHER ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562004 BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192264 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown