BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6144796 · Received December 5, 2016

    Report

    Report Number
    1710034-2016-00061
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 14, 2016
    Report Date
    January 18, 2017
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ON USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED THE UNIT CONSISTED OF THE NEEDLE/BARREL ASSEMBLY AND THE CATHETER/ADAPTER ASSEMBLY. A MICROSCOPIC INSPECTION OBSERVED THE NEEDLE WAS FULLY RETRACTED INTO THE SAFETY BARREL AND THE WHITE BUTTON WAS DEPRESSED. THE NEEDLE WAS ALSO BENT AT THE NOTCH INSIDE OF THE SPRING. THERE WERE NO SIGNS OF BENDS, KINKS, OR WRINKLES IN THE CATHETER TUBING. A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE BENT NEEDLE TIP PREVENTED THE NEEDLE FROM BEING PUSHED AND REPOSITIONED TO THE OUT POSITION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6091799. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE AS REPRODUCTION OF THE DEFECT THAT THE CUSTOMER EXPERIENCED COULD NOT BE ACHIEVED WITH THE TESTING PERFORMED ON THE RETURNED UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE INSERTION OF A 22 G X 1.00 IN. BD INSYTE AUTOGUARD SHIELDED IV CATHETER, THE STYLET APPEARED TO BE "JAMMED" AND THE CATHETER WAS REMOVED. WHEN THE STYLET WAS FORCIBLY REMOVED FROM THE CATHETER, A KINK IN THE STYLET WAS OBSERVED. PRIOR TO THE INSERTION THE CATHETER WAS ABLE TO BE DETACHED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797027 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6091799

    Patients

    Seq Age Sex Outcome Treatment
    1 Other