BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM - DUAL PORT 22 GA 1.00 IN

    MDR report key: 11810591 · Received May 12, 2021

    Report

    Report Number
    1710034-2021-00392
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 13, 2021
    Report Date
    July 7, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED SEALED DEVICES THAT WERE MISSING THE CLAMP. THE REPORTED ISSUE WAS CONFIRMED. MISSING CLAMPS ARE MOST LIKELY THE RESULT OF AN ABNORMALITY IN THE MANUFACTURING PROCESS. OMITTED CLAMPING COMPONENTS, CAN BE THE RESULT OF TOOLING DAMAGE DURING THE AUTOMATED ASSEMBLY PROCESS. TWO IN-LINE AUTOMATED VISION SYSTEMS ARE IN PLACE TO CONFIRM THE PRESENCE OF THE CLAMP AND REMOVE ANY NON-CONFORMING MATERIAL. IN ORDER TO BY-PASS BOTH SYSTEMS THE PALLET OR MOUNT, FOR IN-PROCESS PRODUCTS, WOULD HAVE TO HAVE SUSTAINED DAMAGE THAT COULD HAVE TRIGGERED A FALSE POSITIVE. THIS IS THE ONLY KNOWN OCCURRENCE OF THIS ISSUE BEING REPORTED FOR THIS MANUFACTURING LOT, AND 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 3 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 22 GA 1.00 IN EXPERIENCED MISSING TUBING CLAMPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383532. BATCH NO: 1011121. WE FOUND SOME 22G NEXIVA IVS WITHOUT A LINE CLAMP IN IMAGING TODAY (3 SO FAR). I HAVE REMOVED THEM FROM STOCK. THEY SEEM TO BE LIMITED TO A CERTAIN LOT # 1011121.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 22 GA 1.00 IN EXPERIENCED MISSING TUBING CLAMPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383532, BATCH NO: 1011121. WE FOUND SOME 22G NEXIVA IVS WITHOUT A LINE CLAMP IN IMAGING TODAY (3 SO FAR). I HAVE REMOVED THEM FROM STOCK. THEY SEEM TO BE LIMITED TO A CERTAIN LOT # 1011121.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711580 BD NEXIVA CLOSED IV CATHETER SYSTEM - DUAL PORT 22 GA 1.00 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1011121

    Patients

    Seq Age Sex Outcome Treatment
    1