BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 16483790 · Received March 6, 2023

    Report

    Report Number
    1710034-2023-00184
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 7, 2023
    Report Date
    February 14, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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, 2243842, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED ONLY THE DEVICE'S PACKAGING WHICH SHOWED NO SIGNS OF DAMAGE. THE ACTUAL DEVICE OR DEFECT WERE NOT VISIBLE IN THE PROVIDED PHOTO. THE ENGINEER COULD NOT INSPECT THE DEVICE'S NEEDLE OR RETRACTION ABILITY. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE VISIBLE IN THE PHOTO A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A TREND HAS BEEN IDENTIFIED BY THE MANUFACTURING FACILITY FOR NEEDLES FAILING TO RETRACT PROPERLY. AN INVESTIGATION HAS BEEN OPENED TO IDENTIFY THE CAUSE OF THESE FAILURES. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS' NEEDLES WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSES ARE HAVING TROUBLE WITH OUR 22G ANGIOCATH NEEDLES. THEY ARE HAVING TROUBLE WITH IT NOT RETRACTING. APPARENTLY THEY ARE HAVING TO START PULLING IT OUT BEFORE IT WILL PULL OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513200 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 2243842 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown