BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 5007801 · Received August 12, 2015

    Report

    Report Number
    1710034-2015-00009
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 17, 2015
    Report Date
    May 9, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WEILL BE FILED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULTS: THREE REPRESENTATIVE UNUSED SAMPLES IN SEALED PACKAGES WERE RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC ANALYSIS REVEALED THAT THERE WAS NO MECHANICAL/PHYSICAL DAMAGE TO THE SPRING, NEEDLE HUB, GRIP, OR EVIDENCE OF GLUE ON THE BUTTON OR HUB. A FUNCTIONAL TEST WAS PERFORMED AND REVEALED THAT WHEN THE BUTTON WAS DEPRESSED, THE UNITS DID RETRACT INTO THE SAFETY BARRELS. ADDITIONALLY, THE UNITS WERE TURNED UPSIDE DOWN AND SHOOK, THE NEEDLE DID NOT COME BACK OUT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5019869. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON (B)(6) 2017, (B)(6) WITH FDA MEDWATCH REQUESTED THAT THIS REPORT BE RESUBMITTED WITHOUT THE LEADING ZEROS ON THE MANUFACTURER'S REPORT NUMBER. THIS SUBMISSION IS FOR COMPLIANCE WITH THAT REQUEST. DEVICE EVALUATION: RESULTS: THREE REPRESENTATIVE UNUSED SAMPLES IN SEALED PACKAGES WERE RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC ANALYSIS REVEALED THAT THERE WAS NO MECHANICAL/PHYSICAL DAMAGE TO THE SPRING, NEEDLE, HUB, GRIP, OR EVIDENCE OF GLUE ON THE BUTTON OR HUB. A FUNCTIONAL TEST WAS PERFORMED AND REVEALED THAT WHEN THE BUTTON WAS DEPRESSED, THE UNITS DID RETRACT INTO THE SAFETY BARRELS. ADDITIONALLY, THE UNITS WERE TURNED UPSIDE DOWN AND SHOOK, THE NEEDLE DID NOT COME BACK OUT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5019869. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING A BD INSYTE AUTOGUARD SHIELDED IV CATHETER, THE CLINICIAN ACTIVATED THE SAFETY MECHANISM & DISCARDED THE DEVICE IN A SHARPS CONTAINER. THE NEEDLE THEN CAME OUT OF THE SHARPS CONTAINER & THE CLINICIAN OBTAINED A CONTAMINATED NEEDLE STICK INJURY. THE CLINICIAN RECEIVED ROUTINE POST EXPOSURE LAB WORK, PREVENTATIVE ANTIVIRAL THERAPY, AND WILL HAVE FUTURE MEDICAL EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE CLINICIAN ACTIVATED THE SAFETY MECHANISM AND DISCARDED THE DEVICE IN A SHARPS CONTAINER. THE NEEDLE THEN CAME OUT OF THE SHARPS CONTAINER AND THE CLINICIAN OBTAINED A CONTAMINATED NEEDLE STICK INJURY. THE CLINICIAN RECEIVED ROUTINE POST EXPOSURE LAB WORK, PREVENTATIVE ANTIVIRAL THERAPY, AND WILL HAVE FUTURE MEDICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528992 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5019869

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention