BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6043873 · Received October 20, 2016

    Report

    Report Number
    1710034-2016-00043
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    October 5, 2016
    Report Date
    November 7, 2016
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5300798. THIS LOT WAS MANUFACTURED BETWEEN 10/29/2015 AND 11/01/2015. CONCLUSION - BD WAS UNABLE TO CONFIRM THE CUSTOMER'S REPORTED DEFECT AS NO SAMPLE WAS RETURNED FOR EVALUATION. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIAN STARTED THE IV AS NORMAL BUT THE NEEDLE OF THE SUSPECT DEVICE DID NOT RETRACT INITIALLY. THE ACTIVATION BUTTON HAD TO BE PUSHED A COUPLE OF TIMES IN ORDER FOR THE NEEDLE TO RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694736 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER SHIELDED IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5300798

    Patients

    Seq Age Sex Outcome Treatment
    1 Other