BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 17400587 · Received July 26, 2023

    Report

    Report Number
    1710034-2023-00830
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    June 28, 2023
    Report Date
    August 23, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD DEVICE FROM LOT 3083896 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE NEEDLE WAS ALREADY RETRACTED INSIDE OF THE BARREL. THERE APPEARED TO BE NO DAMAGE TO THE NEEDLE COVER OR THE DEVICE'S COMPONENTS. NEXT, THE UNIT WAS RESET AND THE ENGINEER ATTEMPTED TO ACTIVATE THE SAFETY FEATURE. THE SAFETY MECHANISM ACTIVATED WITHOUT RESISTANCE AND THE NEEDLE RETRACTED SUCCESSFULLY WITH NO ISSUES FOUND. THEREFORE, BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE FOUND DURING INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER RETRACTION FAILURE OCCURRED. THE FOLLOWING WAS RECIEVED BY THE INTITIAL REPORTER VERBATIM: NEEDLES NOT RETRACTING: THIS EVENT WAS REPORTED (B)(6) 2023 T: WHEN INSERTING IVS, THE NEEDLE WILL RETRACT WITH THE BUTTON IS PUSHED ON FIRST ATTEMPT. A: THREE SEPARATE RNS EXPERIENCED INABILITY TO RETRACT THE NEEDLE WHEN THE BUTTON WAS PUSHED. TOOK MULTIPLE ATTEMPTS TO PRESS THE BUTTON BEFORE THE NEEDLE WOULD RETRACT. G: POTENTIAL FOR NEEDLE EXPOSURE SHOULD THE NEEDLE NOT RETRACT AT ALL. DISCOMFORT FOR THE PATIENT AS THE IV IS REPEATEDLY PRESSED/MOVED 9. WAS THERE ANY HARM OR INJURY TO THE PATIENT, HEALTH CARE PROVIDER, OR ANY OTHER PERSON? NO 10. WAS THERE A DELAY OF OR CHANGE IN THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE PROVIDE ANY AVAILABLE DETAILS. NO 11. IF NOT ANSWERED IN QUESTION #2, WHAT WAS THE MEDICATION ADMINISTERED TO THE PATIENT? UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER RETRACTION FAILURE OCCURRED. THE FOLLOWING WAS RECIEVED BY THE INTITIAL REPORTER VERBATIM: NEEDLES NOT RETRACTING: THIS EVENT WAS REPORTED 6/28/23. T: WHEN INSERTING IVS, THE NEEDLE WILL RETRACT WITH THE BUTTON IS PUSHED ON FIRST ATTEMPT. A: THREE SEPARATE RNS EXPERIENCED INABILITY TO RETRACT THE NEEDLE WHEN THE BUTTON WAS PUSHED. TOOK MULTIPLE ATTEMPTS TO PRESS THE BUTTON BEFORE THE NEEDLE WOULD RETRACT. G: POTENTIAL FOR NEEDLE EXPOSURE SHOULD THE NEEDLE NOT RETRACT AT ALL. DISCOMFORT FOR THE PATIENT AS THE IV IS REPEATEDLY PRESSED/MOVED. 9. WAS THERE ANY HARM OR INJURY TO THE PATIENT, HEALTH CARE PROVIDER, OR ANY OTHER PERSON? NO. 10. WAS THERE A DELAY OF OR CHANGE IN THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE PROVIDE ANY AVAILABLE DETAILS. NO. 11. IF NOT ANSWERED IN QUESTION #2, WHAT WAS THE MEDICATION ADMINISTERED TO THE PATIENT? UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965793 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3083896 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown