BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8646787 · Received May 28, 2019

    Report

    Report Number
    9610048-2019-00192
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    April 2, 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

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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 CATHETER LEAKED WITH A BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER. THIS OCCURRED ON 2 SEPARATE OCCASIONS, ADDITIONAL INFORMATION REGARDING THESE OCCASIONS ARE CURRENTLY UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: MATERIAL PRESENTED LEAK WHEN INJECTED WITH MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: TWO ATTEMPTS OF PUNCTURE WERE PERFORMED, WITHOUT SUCCESS, BECAUSE WHEN INJECTING MEDICATION IN THE DEVICE, LEAKAGE WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER LEAKED WITH A BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER. THIS OCCURRED ON 2 SEPARATE OCCASIONS, ADDITIONAL INFORMATION REGARDING THESE OCCASIONS ARE CURRENTLY UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: MATERIAL PRESENTED LEAK WHEN INJECTED WITH MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: TWO ATTEMPTS OF PUNCTURE WERE PERFORMED, WITHOUT SUCCESS, BECAUSE WHEN INJECTING MEDICATION IN THE DEVICE, LEAKAGE WAS OBSERVED.

    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 CATHETER LEAKED WITH A BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER. THIS OCCURRED ON 2 SEPARATE OCCASIONS, ADDITIONAL INFORMATION REGARDING THESE OCCASIONS ARE CURRENTLY UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: MATERIAL PRESENTED LEAK WHEN INJECTED WITH MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: TWO ATTEMPTS OF PUNCTURE WERE PERFORMED, WITHOUT SUCCESS, BECAUSE WHEN INJECTING MEDICATION IN THE DEVICE, LEAKAGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439112 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9003899

    Patients

    Seq Age Sex Outcome Treatment
    1 Other