BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 12330969 · Received August 17, 2021

    Report

    Report Number
    1710034-2021-00713
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    July 19, 2021
    Report Date
    September 14, 2021
    Product Code
    FOZ
    UDI-DI
    30382903825128
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 24GA 0.75IN (0.7 X 19 MM) WAS INVOLVED WITH A PATIENT EXPERIENCING SERIOUS INJURY IN THE FORM OF DIARRHEA, HEPATITIS, AND NAUSEA. IT HAS NOT BEEN SPECIFIED WHETHER MEDICAL INTERVENTION WAS ADMINISTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIARRHEA, HEPATITIS, NAUSEA, INSUFFICIENT INFORMATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 24GA 0.75IN (0.7 X 19 MM). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 24GA 0.75IN (0.7 X 19 MM) WAS INVOLVED WITH A PATIENT EXPERIENCING SERIOUS INJURY IN THE FORM OF DIARRHEA, HEPATITIS, AND NAUSEA. IT HAS NOT BEEN SPECIFIED WHETHER MEDICAL INTERVENTION WAS ADMINISTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIARRHEA, HEPATITIS, NAUSEA, INSUFFICIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229548 SEE H10 INTRAVASCULAR CATHETER FOZ 382512 UNKNOWN 30382903825128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other