BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 15971544 · Received December 13, 2022

    Report

    Report Number
    1710034-2022-00800
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 22, 2022
    Report Date
    January 9, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814343
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED 88 SEALED 20G X 1.16IN. INSYTE AUTOGUARD UNITS FROM LOT NUMBER 2160587. ADDITIONALLY, ONE PHOTO WAS PROVIDED FOR INVESTIGATION. A GROSS VISUAL INSPECTION OF THE RETURNED UNITS DID NOT IDENTIFY ANY DAMAGE/DEFECTS TO THE COMPONENTS. A SAMPLING OF 20 UNITS WERE RANDOMLY SELECTED TO BE FUNCTIONALLY TESTED FOR NEEDLE RETRACTION. ALL UNITS SUCCESSFULLY RETRACTED. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 3 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 AUTOGUARD PIVC FAILED TO SAFETY AFTER CLINICIAN TRIED PUSHING THE BUTTON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 3 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 AUTOGUARD PIVC FAILED TO SAFETY AFTER CLINICIAN TRIED PUSHING THE BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449251 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381434 2160587 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown