BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9318221 · Received November 13, 2019

    Report

    Report Number
    1710034-2019-01221
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 26, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL NO.: 381523 BATCH NO.: 9170878. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER MASSIVE AMOUNTS OF BLOOD IS LEAKING DURING INSERTION OF THE 22 GAUGE CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM A RN AT BAPTIST HEALTH SOUTH FLORIDA AND SEVERAL RN¿S ARE REPORTING MASSIVE AMOUNTS OF BLOOD LEAKING DURING INSERTION OF THE #22 GAUGE CATHETERS. PERHAPS THERE IS A MALFUNCTION IN THE PRODUCT?

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    MATERIAL NO.: 381523, BATCH NO.: 9170878. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER MASSIVE AMOUNTS OF BLOOD IS LEAKING DURING INSERTION OF THE 22 GAUGE CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM A RN AT (B)(6) AND SEVERAL RN¿S ARE REPORTING MASSIVE AMOUNTS OF BLOOD LEAKING DURING INSERTION OF THE #22 GAUGE CATHETERS. PERHAPS THERE IS A MALFUNCTION IN THE PRODUCT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108465 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9170878 30382903815235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other