BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7930602 · Received October 3, 2018

    Report

    Report Number
    9610048-2018-00147
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    June 9, 2018
    Report Date
    October 15, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY# (B)(4), LOT 7241767 MANUFACTURED FROM 01-SEP-17 TO 13-SEP-17 USED IN CLAIMED LOT 7244592. THIS LOT WAS REVIEWED REGARDING THE CLAIMED DEFECT AND WERE NOT EVIDENCED RECORDS THAT COULD LEAD TO CLAIMED DEFECT. THERE ARE NO PHOTOS OR SAMPLES AVAILABLE FOR ANALYSIS. INVESTIGATION CONCLUSION: NOT CONFIRMED: BD WAS UNABLE TO CONFIRM THE CUSTOMER COMPLAINT FOR THE CLAIMED DEFECT. BESIDES TO THE FACT THAT HAVE NOT BEEN FOUND RECORDS THAT COULD CAUSE THIS COMPLAINT DURING THE ANALYSIS OF DEVICE HISTORY RECORD, OF NON-CONFORMITIES, WITHOUT SAMPLES OR PHOTOS FOR ANALYSIS, IT IS NOT POSSIBLE TO CONFIRM THE DEFECT REPORTED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD SHIELDED IV CATHETER HAD LEAKAGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD LEAKAGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773339 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7244592 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other