BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 10141309 · Received June 10, 2020

    Report

    Report Number
    1710034-2020-00366
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    May 21, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A SAMPLE WAS RECEIVED WITH A CURVED NEEDLE TIP AND PHOTOGRAPHS WERE FORWARDED TO THE MANUFACTURING SITE FOR EVALUATION. BD RECEIVED FOUR PHOTOGRAPHS WHICH DISPLAYED A BENT NEEDLE. THE NEEDLE WAS OBSERVED BENT AT THE NOTCH NEAR THE NEEDLE TIP. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN EXPERIENCED A BROKEN/DETACHED NEEDLE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A NEEDLE WAS BROKEN BEFORE USE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN. 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 EXPERIENCED A BROKEN/DETACHED NEEDLE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A NEEDLE WAS BROKEN BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605229 SEE H10 INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9238895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other