BEUDAMED
    FDA Adverse Event Death Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 18540077 · Received January 18, 2024

    Report

    Report Number
    3002695476-2024-00004
    Event Type
    Death
    Date Received
    January 18, 2024
    Date of Event
    October 13, 2023
    Report Date
    January 18, 2024
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    PMA / PMN Number
    K083042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AWAITING RESPONSE FROM THE CUSTOMER TO OBTAIN MORE INFORMATION ABOUT THE AFFECTED PRODUCT.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED INFORMATION ABOUT THE PRODUCT THAT WAS USED AND IT IS CONFIRMED THAT THE PRODUCT IS NOT MANUFACTURED BY NURSE ASSIST.

    Description of Event or Problem · 0

    ON (B)(6) 2024, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL. DESCRIPTION OF REPORT: MY NAME IS (B)(6). I RECEIVED NOTIFICATION ABOUT A RECALL ON PRE FILLED NORMAL SALINE SYRINGES WITH EXPIRATION DATES 11/6/23 TO 09/18/2025 THAT WERE PRESCRIBED AND BEING USED BY MY BROTHER (B)(6) WITH AN ADDRESS OF (B)(6). (B)(6) UNFORTUNATELY PASSED AWAY (B)(6) 2023 AFTER BECOMING SEPTIC AND DEVELOPED PNEUMONIA WHILE RECEIVING ANTIBIOTICS THROUGH A PIC-LINE. IT DEFINITELY WAS VERY CONCERNING RECEIVING A LETTER THAT THIS PRODUCT HAD BEEN RECALLED DUE TO A QUESTION ABOUT STERILITY. ANY INFORMATION YOU MAY HAVE REGARDING THIS WOULD BE HELPFUL.

    Description of Event or Problem · 0

    ON 15-JAN-2024, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL. DESCRIPTION OF E-MAIL: MY NAME IS (B)(6). I RECEIVED NOTIFICATION ABOUT A RECALL ON PRE FILLED NORMAL SALINE SYRINGES WITH EXPIRATION DATES 11/6/2023 TO 09/18/2025 THAT WERE PRESCRIBED AND BEING USED BY MY BROTHER (B)(6) WITH AN ADDRESS OF (B)(6). (B)(6) UNFORTUNATELY PASSED AWAY (B)(6) 2023 AFTER BECOMING SEPTIC AND DEVELOPED PNEUMONIA WHILE RECEIVING ANTIBIOTICS THROUGH A PIC-LINE. IT DEFINITELY WAS VERY CONCERNING RECEIVING A LETTER THAT THIS PRODUCT HAD BEEN RECALLED DUE TO A QUESTION ABOUT STERILITY. ANY INFORMATION YOU MAY HAVE REGARDING THIS WOULD BE HELPFUL. ON 19-JAN-2024, NURSE ASSIST RECEIVED MORE INFORMATION ABOUT THE COMPLAINT THAT WAS RECEIVED ON 15-JAN-2024. DESCRIPTION OF E-MAIL: THE PRODUCT THAT WAS USED ON (B)(6) IS NOT A NURSE ASSIST PRODUCT. THE IMAGE OF THE PRODUCT PROVIDED HAD A LOT NUMBER AND UDI CODE THAT IS NOT FROM NURSE ASSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063461 NURSE ASSIST, LLC 0.9% SODIUM CHLORIDE I.V. FLUSH PREFILLED SYRINGE FRO NURSE ASSIST, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death