BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.00IN HF Y

    MDR report key: 12028508 · Received June 18, 2021

    Report

    Report Number
    1710034-2021-00515
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 20, 2021
    Report Date
    July 12, 2021
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 20GA 1.00IN HF Y LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLELESS CONNECTOR CAME OFF, UNBEKNOWN TO STAFF FOR SOMETIME, BEFORE IT WAS REALIZED, THE PATIENT LOST A LOT OF BLOOD BEFORE A STAFF MEMBER FOUND IT WAS OFF AND THE EXTENSION SET WAS NOT CLAMPED. AS A RESULT BLOOD WAS IN THE BED AND ONTO THE FLOOR. PATIENT BP DID DROP BY 20MMHG, AS HE WAS HYPERTENSIVE, IT CAUSED HIS BLOOD PRESSURE TO THEN BE LOWER, NO HARM TO PATIENT DUE TO THE STAFF MEMBER FINDING THE CANNULA BLEEDING AND UNCLAMPED OR UNCAPPED BY A NEEDLELESS CONNECTOR.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEXIVA 20GA 1.00IN HF Y LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLELESS CONNECTOR CAME OFF, UNBEKNOWN TO STAFF FOR SOMETIME, BEFORE IT WAS REALIZED, THE PATIENT LOST A LOT OF BLOOD BEFORE A STAFF MEMBER FOUND IT WAS OFF AND THE EXTENSION SET WAS NOT CLAMPED. AS A RESULT BLOOD WAS IN THE BED AND ONTO THE FLOOR. PATIENT BP DID DROP BY 20MMHG, AS HE WAS HYPERTENSIVE, IT CAUSED HIS BLOOD PRESSURE TO THEN BE LOWER, NO HARM TO PATIENT DUE TO THE STAFF MEMBER FINDING THE CANNULA BLEEDING AND UNCLAMPED OR UNCAPPED BY A NEEDLELESS CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920449 NEXIVA 20GA 1.00IN HF Y INTRAVASCULAR CATHETER FOZ UNKNOWN 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1