BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ IV CATHETER

    MDR report key: 9781440 · Received March 3, 2020

    Report

    Report Number
    9610048-2020-00033
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 11, 2020
    Report Date
    April 2, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE DEFECT FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 5040301, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO BUT COULD NOT IDENTIFY ANY VISIBLE DEFECTS WITH THE UNIT. BASED ON THE PROVIDED PHOTO THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE OBSERVED IN THE PHOTO A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER WAS UNABLE TO PROPERLY CONNECT WITH ANY EXTENSION. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN TRYING TO CONNECT ANY EXTENSION, IT DOES NOT TWIST CORRECTLY, IT IS ATTEMPTED WITH SHORT EXTENSION, WITH BIFURCATED, WITH THREE-WAY AND NEEDLE-FREE CONNECTORS, PUMP EQUIPMENT AND WITH NO DEVICE IT IS ABLE TO CONNECT TO THE CATHETER. IT IS NECESSARY TO WITHDRAW THE ACCESS AND RE-PUNCTURE THE PATIENT WITH ANOTHER BRAND OF CATHETER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER WAS UNABLE TO PROPERLY CONNECT WITH ANY EXTENSION. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN TRYING TO CONNECT ANY EXTENSION, IT DOES NOT TWIST CORRECTLY, IT IS ATTEMPTED WITH SHORT EXTENSION, WITH BIFURCATED, WITH THREE-WAY AND NEEDLE-FREE CONNECTORS, PUMP EQUIPMENT AND WITH NO DEVICE IT IS ABLE TO CONNECT TO THE CATHETER. IT IS NECESSARY TO WITHDRAW THE ACCESS AND RE-PUNCTURE THE PATIENT WITH ANOTHER BRAND OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246532 BD INSYTE¿ IV CATHETER N/A FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5040301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other