BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6139736 · Received December 1, 2016

    Report

    Report Number
    9610048-2016-00008
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 14, 2016
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6123469. A MANUFACTURING REVIEW REVEALED A DEVIATION (16D011) THAT MAY BE RELATED TO THE CUSTOMER'S REPORTED FAILURE MODE (SAFETY ACTIVATION FAILURE). CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. ALTHOUGH A DEVIATION WAS DISCOVERED IN THE MANUFACTURING REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THIS DEVIATION CAUSED THE CUSTOMER'S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN., THE SAFETY MECHANISM FAILED TO FUNCTION PROPERLY. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. ADDITIONAL INFORMATION REGARDING THIS INCIDENT IS UNKNOWN AS THE COMPLAINT WAS RECEIVED FROM THE (B)(6) REGULATORY AGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790769 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN. INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6123469

    Patients

    Seq Age Sex Outcome Treatment
    1 Other