BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 16607641 · Received March 23, 2023

    Report

    Report Number
    1710034-2023-00301
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    March 1, 2023
    Report Date
    April 11, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815334
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION FOR THE REPORTED ITEM NUMBER 381533. BD DID RECEIVE SAMPLES, BUT THEY WERE NOT ALIGNED WITH THE REPORT SUBMITTED. MULTIPLE ATTEMPTS WERE MADE FOR CLARIFICATION WITH THE SAMPLES RECEIVED. WE RECEIVED THE FOLLOWING REPRESENTATIVE UNITS: 191 UNITS LOT NUMBER 2336528. 4 UNITS LOT NUMBER 2063749. 2 UNITS LOT NUMBER 2101809. 3 UNITS LOT NUMBER 1111845. 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.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON LOOKING AT PRODUCT THEY HAVE A BARB THAT TEARS THE VEIN WHEN STARTING IV¿S.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON LOOKING AT PRODUCT THEY HAVE A BARB THAT TEARS THE VEIN WHEN STARTING IV¿S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376944 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381533 UNKNOWN 30382903815334

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown