BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17664311 · Received August 31, 2023

    Report

    Report Number
    1710034-2023-00993
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 14, 2023
    Report Date
    September 22, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    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. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL THE NEEDLE DID NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE NURSES TODAY SHARED THAT SHE STARTED AN IV AND THE SAFETY MECHANISM WOULD NOT WORK. SHE SHARED WHEN SHE REMOVED THE CATHETER SHE WAS ABLE TO GET IT TO WORK BUT SHE HAD TO PRESS EXTREMELY HARD FOR THE BUTTON TO ENGAGE. SHE SHARE A FEW OTHER NURSES MENTIONED THEY HAVE THIS HAPPEN RECENTLY TOO. UNFORTUNATELY, THE WRAPPER SHE SAVED ISN'T FOR THE CATH FOR A LOT NUMBER, BUT I DO HAVE THE CATHETER ITSELF IF YOU WOULD LIKE TO SEND IT OFF FOR INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL THE NEEDLE DID NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE NURSES TODAY SHARED THAT SHE STARTED AN IV AND THE SAFETY MECHANISM WOULD NOT WORK. SHE SHARED WHEN SHE REMOVED THE CATHETER SHE WAS ABLE TO GET IT TO WORK BUT SHE HAD TO PRESS EXTREMELY HARD FOR THE BUTTON TO ENGAGE. SHE SHARE A FEW OTHER NURSES MENTIONED THEY HAVE THIS HAPPEN RECENTLY TOO. UNFORTUNATELY, THE WRAPPER SHE SAVED ISN'T FOR THE CATH FOR A LOT NUMBER, BUT I DO HAVE THE CATHETER ITSELF IF YOU WOULD LIKE TO SEND IT OFF FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514549 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3166524 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown