BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8484653 · Received April 4, 2019

    Report

    Report Number
    9610048-2019-00145
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 5, 2019
    Report Date
    August 31, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD WAS ABLE TO VERIFY FROM THE RETURNED SAMPLE WHITE POINTS THAT MAY HAVE ORIGINATED FROM THE PACKAGING. ALTHOUGH NO FOREIGN MATTER RECORDS WERE FOUND IN THE BATCH HISTORY ANALYZES AND IN THE RECORDS OF NON-CONFORMITY OR CORRECTIVE MAINTENANCE FOR THE CLAIMED BATCH, AS A POSSIBLE CAUSE OF THIS DEFECT WOULD HAVE ORIGINATED FROM THE RAW MATERIAL.

    Additional Manufacturer Narrative · 0

    CORRECTION: D3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SANDY, UT. G1. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SANDY, UT. THE PRODUCT IS MADE IN SANDY, UT AND PACKAGED IN JUIZ DE FORA, BR. THIS REPORT ERRANTLY REPORTED THE MANUFACTURER AS JUIZ DE FORA, BR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WHEN THE PACKAGE WAS OPENED, WHITE MICRO PARTICLES WERE OBSERVED OUTSIDE THE CATHETER. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WHEN THE PACKAGE WAS OPENED, WHITE MICRO PARTICLES WERE OBSERVED OUTSIDE THE CATHETER. INFORMATION RECEIVED BY EMAIL ON 3/22/2019: THE INCIDENT WAS NOTICED IN THE MOMENT THAT THE PACKAGE WAS OPENED. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THE WHITE PARTICLES WAS IDENTIFIED INSIDE THE PLASTIC PACKAGE, ABOVE THE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WHEN THE PACKAGE WAS OPENED, WHITE MICRO PARTICLES WERE OBSERVED OUTSIDE THE CATHETER. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WHEN THE PACKAGE WAS OPENED, WHITE MICRO PARTICLES WERE OBSERVED OUTSIDE THE CATHETER. INFORMATION RECEIVED BY EMAIL ON 3/22/2019: THE INCIDENT WAS NOTICED IN THE MOMENT THAT THE PACKAGE WAS OPENED. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THE WHITE PARTICLES WAS IDENTIFIED INSIDE THE PLASTIC PACKAGE, ABOVE THE SHIELD.

    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 DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WHEN THE PACKAGE WAS OPENED, WHITE MICRO PARTICLES WERE OBSERVED OUTSIDE THE CATHETER. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN THE PACKAGE WAS OPENED, WHITE MICRO PARTICLES WERE OBSERVED OUTSIDE THE CATHETER. INFORMATION RECEIVED BY EMAIL ON 3/22/2019: THE INCIDENT WAS NOTICED IN THE MOMENT THAT THE PACKAGE WAS OPENED. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THE WHITE PARTICLES WAS IDENTIFIED INSIDE THE PLASTIC PACKAGE, ABOVE THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274915 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8330592

    Patients

    Seq Age Sex Outcome Treatment
    1 Other