BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8765270 · Received July 5, 2019

    Report

    Report Number
    1710034-2019-00716
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 19, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW THIS COMPLAINT HAS BEEN DEEMED NOT REPORTABLE AS IT IS GENERAL DISSATISFACTION. THE CUSTOMER IS COMPLAINING ABOUT THAT THE PRODUCT DID NOT HAVE AS LONG OF A SHELF LIFE AS THE CONSUMER WOULD'VE LIKED. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. AS A RESULT MFR# 1710034-2019-00716 IS NULL AND VOID AS IT IS NO LONGER REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD INCORRECT LABEL INFORMATION. THIS OCCURRED ON 800 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINED ABOUT LOT BACK. ALSO OLD PACKAGED PRODUCTS WERE DELIVERED.

    Additional Manufacturer Narrative · 1

    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¿ BC SHIELDED IV CATHETER HAD INCORRECT LABEL INFORMATION. THIS OCCURRED ON 800 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINED ABOUT LOT BACK. ALSO OLD PACKAGED PRODUCTS WERE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559314 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8127945

    Patients

    Seq Age Sex Outcome Treatment
    1 Other