BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY

    MDR report key: 12969006 · Received December 9, 2021

    Report

    Report Number
    1710034-2021-01039
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 10, 2021
    Report Date
    December 21, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11/29/2021. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED 50 SEALED 22G X 1.00IN. INSYTE AUTOGUARD BC PRO UNITS FROM LOT NUMBER 1111856. IN ADDITION, FIVE PHOTOGRAPHS WERE PROVIDED FOR INVESTIGATION. A GROSS VISUAL INSPECTION OF THE RETURNED UNITS FOUND THAT NINE OF THE UNITS HAD TEARS ON THE TOP WEB NEAR THE PROXIMAL END OF THE BARREL. THE TEARS HAD STAINS ON THE TOP AND BOTTOM SIDE OF THE TOP WEB. THE SHAPE OF THE TEAR WAS IN EITHER A SEMI-CIRCLE SHAPE OR V-SHAPE. THE TEARS ON SOME OF THE UNITS WERE ROLLED BACK AND UP AS IF IT THE MATERIAL WAS PEELED BACK. NO DAMAGE WAS NOTED TO THE RETURNED DISPENSER BOX OR THE BOTTOM WEB OF THE TORN UNITS. THE REPORTED ISSUE WAS CONFIRMED. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS BLOOD CONTROL TECHNOLOGY HAD A DAMAGED UNIT PACKAGE THAT COMPROMISED STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " DURING INSPECTION AT THE CUSTOMER'S SIDE, 10 PACKAGES WERE FOUND TO BE DAMAGED/TORN.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS BLOOD CONTROL TECHNOLOGY HAD A DAMAGED UNIT PACKAGE THAT COMPROMISED STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " DURING INSPECTION AT THE CUSTOMER'S SIDE, 10 PACKAGES WERE FOUND TO BE DAMAGED/TORN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865395 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1111856

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown