BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10116442 · Received June 3, 2020

    Report

    Report Number
    1710034-2020-00354
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    April 30, 2020
    Report Date
    July 6, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH THREE PHOTOS OF THE DEFECT FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 9170870, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS AND DETERMINED THAT CATHETER ADAPTER WAS INCORRECTLY ORIENTED AND LODGED WITH THE NEEDLE COVER. THERE WAS NO DAMAGE OBSERVED TO THE END OF THE CATHETER. BASED OFF THE PROVIDED PHOTOS THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. HOWEVER, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR TESTING A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS ATTACHED INSIDE THE NEEDLE SHIELD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MATERIAL WAS OPENED IN ORDER TO PERFORM THE PUNCTURE (B)(6) 2020), THE SHIELD WAS REMOVED AND THE CATHETER GOT ATTACHED INSIDE THE SHIELD AND SO THE NEEDLE WAS WITHOUT THE CATHETER 20.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS ATTACHED INSIDE THE NEEDLE SHIELD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MATERIAL WAS OPENED IN ORDER TO PERFORM THE PUNCTURE ((B)(4) 2020), THE SHIELD WAS REMOVED AND THE CATHETER GOT ATTACHED INSIDE THE SHIELD AND SO THE NEEDLE WAS WITHOUT THE CATHETER 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578108 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 9170870 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other