BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 17799641 · Received September 22, 2023

    Report

    Report Number
    1710034-2023-01094
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 16, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 3083635, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED AND 18 GAUGE INSYTE AUTOGUARD DEVICE THAT WAS PARTIALLY RETRACTED INSIDE OF THE NEEDLE GRIP. THE SAFETY ACTIVATION FEATURE APPEARED TO HAVE BEEN ACTIVATED BUT THE NEEDLE FAILED TO RETRACT COMPLETELY. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. 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 IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE TIP WOULD NOT RETRACT AFTER INSERTING IT INTO THE PATIENT. THIS OCCURRED WITH 2 CATHETERS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE HEAD NURSE IN THE OPERATING ROOM REMOVED THE NEEDLE AFTER INSERTING IT INTO THE PATIENT AND FOUND THAT THE NEEDLE TIP DID NOT REBOUND AFTER THE SAFETY DEVICE WAS INSTALLED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE TIP WOULD NOT RETRACT AFTER INSERTING IT INTO THE PATIENT. THIS OCCURRED WITH 2 CATHETERS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE HEAD NURSE IN THE OPERATING ROOM REMOVED THE NEEDLE AFTER INSERTING IT INTO THE PATIENT AND FOUND THAT THE NEEDLE TIP DID NOT REBOUND AFTER THE SAFETY DEVICE WAS INSTALLED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872396 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3083635

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown