BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN.

    MDR report key: 7025520 · Received November 13, 2017

    Report

    Report Number
    9610048-2017-00064
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    September 23, 2017
    Report Date
    December 18, 2017
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BASED ON THE ANALYSIS OF THE SAMPLE RETURNED FROM THE CLIENT, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT, SINCE NO CHARACTERISTICS WERE DETECTED IN ANY OF THE ANALYZED SAMPLE COMPONENTS THAT COULD CAUSE AN ACTIVATION FAILURE. IN ADDITION, THERE ARE NO RECORDS IN PRODUCTION HISTORIES, NON-CONFORMITIES OR CORRECTIVE MAINTENANCE THAT COULD CLEARLY LEAD TO THIS COMPLAINT FOR THE LOT INVOLVED IN THIS COMPLAINT. BASED ON THE INVESTIGATIONS OF THIS COMPLAINT, IT WAS NOT POSSIBLE TO ASSIGN A ROOT CAUSE FOR THE INCIDENT TO DATE SINCE THE COMPLAINT WAS NOT CONFIRMED. SAMPLES/ PHOTOS: IT WAS RECEIVED ONE SAMPLE OPENED AND UNUSED OF INSYTE AUTOGUARD 22G X 1.00, CATALOG NUMBER 38182314 FROM LOT: 7122627. AFTER VISUAL ANALYSIS OF THE SAMPLE, WERE NO DETECTED DAMAGE OR CHARACTERISTICS IN ANY OF THE COMPONENTS (BARREL, GRIP, BOTTOM) OF THE PRODUCT THAT COULD LEAD TO A FAILURE TO ACTIVATE THE SAFETY DEVICE. DHR REVIEW: THE ASSEMBLY LOT: 7116584, USED IN THE CLAIMED FINAL PRODUCT LOT: 7122627 OF INSYTE AUTOGUARD 22G X 1.00 WAS ANALYZED FOR "NEEDLE RETRACTION" AND ¿PART ACTIVATION¿ TESTS, AND IT WAS NOT EVIDENCED RECORD OF FAILURE OF ACTIVATION OF THE PART DURING THE ANALYSIS OF THESE BATCHES. QN/ NCMR REVIEW: THERE ARE NO QN RECORDS OF THIS DEFECT FOR BATCHES RELATED IN THIS COMPLAINT. UNPLANNED MAINTENANCE: THE CORRECTIVE MAINTENANCE HISTORY IN THE MANUFACTURING PERIOD OF THE ASSEMBLY LOT INVOLVED IN THIS COMPLAINT WAS EVALUATED AND NO RECORDS WERE RECORDED THAT COULD CLEARLY INDICATE A FAILURE OF THE ACTIVATION OF THE PART. NOT CONFIRMED: BD WAS UNABLE TO CONFIRM THE INCIDENT IN QUESTION.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN FAILED TO FUNCTION PROPERLY DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803225 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN. INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7122627 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other