BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL

    MDR report key: 17065582 · Received June 5, 2023

    Report

    Report Number
    1710034-2023-00613
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 20, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?YES. D10: RETURNED TO MANUFACTURER ON: 22-MAY-2023 H6: INVESTIGATION SUMMARY BD RECEIVED TWO UNSEALED 20 GAUGE INSYTE AUTOGUARD UNIT FROM LOT 2220955 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 UNITS AND OBSERVED THAT ONE OF THE UNITS WAS STUCK INSIDE OF THE CATHETER AND NOT FULLY RETRACTED BECAUSE THE NEEDLE WAS SLIGHTLY BENT NEAR THE NOTCH OF THE CANNULA. THE OTHER UNIT APPEARED TO NOT HAVE ANY DEFECT OR DAMAGE VISIBLE AND MET PRODUCT SPECIFICATIONS. THEREFORE, BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT OF NEEDLE BENT. UNFORTUNATELY, THE ENGINEER WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE OBSERVED DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL THE NEEDLE HAD A DEFECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTED NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL THE NEEDLE HAD A DEFECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTED NEEDLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093100 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382533 2220955 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown