BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿

    MDR report key: 7496372 · Received May 8, 2018

    Report

    Report Number
    9610048-2018-00058
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    March 12, 2018
    Report Date
    May 30, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLES/ PHOTOS: SAMPLES HAVE NOT RECEIVED FOR ANALYSIS OF THE INCIDENT IN QUESTION. DHR REVIEW: THE FOLLOWING ASSEMBLY BATCH USED IN THE FINAL CLAIMED PRODUCT LIST 7244583 WAS ANALYZED: THE FINAL ASSEMBLY LOT: 7241767 ASSEMBLED IN THE PERIOD FROM 09/01/2017 TO 09/13/2017. THE BATCH 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: NO RECORDS OF QUALITY NOTIFICATION OR REPORTS OF NON-CONFORMITY THAT COULD LEAD TO INCIDENTS IN TO THE LOT INVOLVED IN THIS COMPLAINT WERE EVIDENCED. 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. INVESTIGATION CONCLUSION: NOT CONFIRMED: BD WAS UNABLE TO CONFIRM THE CLAIMED DEFECT. SINCE SAMPLES CONTAINING THE DEFECT CLAIMED ARE NOT AVAILABLE FOR REVIEW, THIS COMPLAINT WAS NOT CONFIRMED. IN ADDITION, THERE ARE NO NON-CONFORMITIES OR CORRECTIVE MAINTENANCE IN THE LOTS INVOLVED IN THIS COMPLAINT, WHICH COULD CONFIRM THE DEFECT CLAIMED WITHOUT PRESENCE OF SAMPLES.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ THERE WAS AN ISSUE WITH NEEDLE RETRACTION FAILURE. IT WAS STATED ¿THE SAFETY MECHANISM OF THE CATHETER DID NOT ACTIVATE AFTER PUNCTURE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336255 BD INSYTE¿ AUTOGUARD¿ INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7244583 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other