BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 10839981 · Received November 13, 2020

    Report

    Report Number
    1710034-2020-00727
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 20, 2020
    Report Date
    December 11, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, 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. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM) EXPERIENCED A BLOOD CONTROL FEATURE THAT WOULD NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY HAVE HAD TWO INCIDENTS WHERE THERE WAS NO BLOOD CONTROL VALVE IN THE CATHETERS OR IT WAS MALFUNCTIONING. REF (B)(4). LOT 0191483. MYSELF AND ANOTHER RN ARE USING REF (B)(4). INSYTE AND NOW HAVE HAD 2 INSTANCES THAT THERE IS NO BACK FLOW VALVE IN THEM WHEN WE ANTICIPATE THAT THEY SHOULD. THIS PARTICULAR ONE SHOULD HAVE. AFTER THE NEEDLE WAS DISENGAGED; THE CATHETER DID NOT HAVE A VALVE TO STOP BLOOD FROM COMING OUT OF END BEFORE IV FLUID WAS CONNECTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE BRAND NAME: BD INSYTE" AUTOGUARD" BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE" AUTOGUARD" BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM) EXPERIENCED A BLOOD CONTROL FEATURE THAT WOULD NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY HAVE HAD TWO INCIDENTS WHERE THERE WAS NO BLOOD CONTROL VALVE IN THE CATHETERS OR IT WAS MALFUNCTIONING. REF 382523. LOT 0191483 MYSELF AND ANOTHER RN ARE USING REF 382523 INSYTE AND NOW HAVE HAD 2 INSTANCES THAT THERE IS NO BACK FLOW VALVE IN THEM WHEN WE ANTICIPATE THAT THEY SHOULD. THIS PARTICULAR ONE SHOULD HAVE. AFTER THE NEEDLE WAS DISENGAGED; THE CATHETER DID NOT HAVE A VALVE TO STOP BLOOD FROM COMING OUT OF END BEFORE IV FLUID WAS CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305861 SEE H10 INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 0191483 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1