BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.00IN HF Y

    MDR report key: 12145658 · Received July 9, 2021

    Report

    Report Number
    1710034-2021-00562
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 21, 2021
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PICTURE SAMPLES RETURNED FOR EVALUATION. BD RECEIVED FOUR PICTURE SAMPLES FOR THIS INCIDENT. VISUAL OBSERVATION OF THE PICTURES SHOWS THE NEEDLE PIERCING THROUGH THE CATHETER SHORTLY ABOVE THE ADAPTER NOSE. AS THE DEVICE SHOWS SIGNS OF USE, IT IS VERY UNLIKELY THAT THIS DEFECT ORIGINATED DURING THE MANUFACTURING PROCESS, AS THE CUSTOMER WOULD HAVE RECEIVED THE NEEDLE PIERCED THROUGH THE CATHETER WALL WITH A Y-SHAPE. IF AN ATTEMPT WAS MADE TO INSERT THE CATHETER WITH A Y-SHAPE, THE NEEDLE WOULD NOT ADVANCE INTO THE PATIENT¿S SKIN PAST THE SPEAR, CAUSING EXCESSIVE PAIN. IF THE CATHETER WAS SPEARED BEFORE INSERTION AT THE LENGTH SHOWN IN THE PICTURES, BLOOD WOULD NOT HAVE BEEN ABLE TO REACH THE TIP OF THE CATHETER, UNLIKE WHAT IS SHOWN IN THE PICTURES PROVIDED. BASED ON THE INVESTIGATION RESULTS, THE DEVICE WAS MOST LIKELY PIERCED WHEN VENIPUNCTURE WAS PERFORMED IN 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 NEXIVA 20GA 1.00IN HF Y CATHETER SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT IV NEEDLE SPLIT IN TWO.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT NEXIVA 20GA 1.00IN HF Y CATHETER SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT IV NEEDLE SPLIT IN TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041379 NEXIVA 20GA 1.00IN HF Y INTRAVASCULAR CATHETER FOZ 1061530 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1