BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6327434 · Received February 13, 2017

    Report

    Report Number
    1710034-2017-00023
    Event Type
    Injury
    Date Received
    February 13, 2017
    Date of Event
    January 29, 2017
    Report Date
    February 22, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE UNUSED REPRESENTATIVE SAMPLES IN SEALED PACKAGES WERE RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION REVEALED NO MECHANICAL OR PHYSICAL DAMAGE TO ANY OF THE SPRINGS, NEEDLE HUBS, GRIPS, OR EVIDENCE OF ADHESIVE ON THE BUTTONS OR HUBS. A SIMULATED USE TEST WAS PERFORMED BY PRESSING THE SAFETY ACTIVATION BUTTON ON ALL THREE UNITS AND THE NEEDLES ON ALL THREE UNITS RETRACTED INTO THEIR SAFETY BARRELS. 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 # 6112780. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THERE WAS NO DEFINITE PHYSICAL OR MECHANICAL EVIDENCE THAT CONFIRMED AND SUPPORTED MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT OBSERVED IN THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER STARTING AN IV WITH A 18 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER, THE NEEDLE THAT WAS PROPERLY RETRACTED SLID OUT OF THE DEVICE WHILE A PARAMEDIC WAS DISPOSING IT AND HE OBTAINED A CONTAMINATED NEEDLE STICK INJURY. THE PARAMEDIC WAS EVALUATED IN AN EMERGENCY DEPARTMENT AND RECEIVED POST EXPOSURE LAB WORK. THE SOURCE PATIENT ALSO CONSENTED TO AND RECEIVED POST EXPOSURE LAB WORK. THE TEST RESULTS ARE UNKNOWN. THE PARAMEDIC DID NOT RECEIVE ANY PROPHYLAXIS AND NO OTHER MEDICAL INTERVENTIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110031 18 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6112780

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention