BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 14780412 · Received June 22, 2022

    Report

    Report Number
    1710034-2022-00310
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 28, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 05-JUL-2022. INVESTIGATION SUMMARY BD RECEIVED AN 22 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 1160982 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 NOT FULLY RETRACTED. NEXT, THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND IT REVEALED THAT THERE WAS SOME ADHESIVE BETWEEN THE ACTIVATION BUTTON AND THE NEEDLE HUB PREVENTING SUCCESSFUL RETRACTION. THEREFORE, BASED OFF THE VISUAL AND MICROSCOPIC INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WOULD NOT RETRACT WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE CANNOT BE RETRACTED WHEN ACTIVATED THE PUSH-BUTTON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WOULD NOT RETRACT WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE CANNOT BE RETRACTED WHEN ACTIVATED THE PUSH-BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328697 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1160982

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown