BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 11227606 · Received January 25, 2021

    Report

    Report Number
    1710034-2021-00056
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    January 6, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814238
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A USED 22 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 9252564 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 HAD PIERCED THROUGH THE CATHETER TUBING NEAR THE TIP. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE IT APPEARED THAT THE DEVICE HAD BEEN USED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE PUNCTURED THROUGH THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WHEN RETRACTING IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNFORTUNATELY AN INCIDENT HAD HAPPENED AGAIN WITH THE NEEDLE HAD PUNCTURE THE CATHETER WHEN RETRACTING. IT WAS WITH THE 22G #381423, LOT 9252564."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE PUNCTURED THROUGH THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WHEN RETRACTING IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNFORTUNATELY AN INCIDENT HAD HAPPENED AGAIN WITH THE NEEDLE HAD PUNCTURE THE CATHETER WHEN RETRACTING. IT WAS WITH THE 22G (B)(4), LOT 9252564."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120994 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 9252564 30382903814238

    Patients

    Seq Age Sex Outcome Treatment
    1