BEUDAMED
    FDA Adverse Event Death Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 18475015 · Received January 9, 2024

    Report

    Report Number
    3002695476-2023-00050
    Event Type
    Death
    Date Received
    January 9, 2024
    Date of Event
    October 4, 2023
    Report Date
    January 4, 2024
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    PMA / PMN Number
    K083042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 03-JAN-2024, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM RQA STATING THAT THEY RECEIVED A VOICEMAIL FROM (B)(6) ABOUT HER HUSBAND DYING DUE TO THE PRODUCT. DESCRIPTION OF THE VOICEMAIL: "YES, MY NAME IS (B)(6). MY NUMBER IS (B)(6). IT IS (B)(6) AT ABOUT 12:35PM CENTRAL TIME. I AM CALLING ABOUT THE MCKESSON STERILE WATER. FDA CLASS 1, RECALL. MY HUSBAND UTILIZED THAT AND HE DIED A SEPTIC SHOCK. AND THE SOURCE WAS THOUGHT TO BE HIS BILIARY TUBES, WHICH HE USED YOUR PRODUCT TO FLUSH HIS TUBES. YOU LIKE TO CALL ME BACK, MY NAME IS (B)(6). (B)(6), THANK YOU." ON (B)(6) 2024, NURSE ASSIST REACHED OUT TO (B)(6) TO OBTAIN MORE INFORMATION ABOUT THE ADVERSE EVENT. DESCRIPTION FROM THE PHONE CALL: (B)(6) PURCHASED A CASE OF 37-6260 FROM AMAZON BETWEEN JULY TO SEPTEMBER. KRAMER USED THE BOTTLES FOR IRRIGATING HER HUSBAND'S BILIARY TUBE. HUSBAND EVENTUALLY DIED ON (B)(6) 2023 DUE TO SEPTIC SHOCK. (B)(6) BELIEVES THE 37-6260 BOTTLES THAT WERE USED TO CLEAN HER HUSBAND'S BILIARY TUBES ARE LINKED TO HER HUSBAND'S DEATH. HUSBAND HAD UNDERLYING ILLNESS (CANCER) PRIOR TO USING NURSE ASSIST PRODUCT. (B)(6) USED STERILE SYRINGES TO WITHDRAW THE STERILE WATER IN THE BOTTLES TO IRRIGATE HER HUSBAND'S BILIARY TUBE. (B)(6) WOULD REUSE THE BOTTLES AFTER ITS INITIAL USE.

    Description of Event or Problem · 0

    ON 03-JAN-2024, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM RQA STATING THAT THEY RECEIVED A VOICEMAIL FROM (B)(6) ABOUT HER HUSBAND DYING DUE TO THE PRODUCT. DESCRIPTION OF THE VOICEMAIL: "YES, MY NAME IS (B)(6). MY NUMBER IS (B)(6). IT IS (B)(6) AT ABOUT 12:35PM CENTRAL TIME. I AM CALLING ABOUT THE MCKESSON STERILE WATER. FDA CLASS 1, RECALL. MY HUSBAND UTILIZED THAT AND HE DIED A SEPTIC SHOCK. AND THE SOURCE WAS THOUGHT TO BE HIS BILIARY TUBES, WHICH HE USED YOUR PRODUCT TO FLUSH HIS TUBES. YOU LIKE TO CALL ME BACK, MY NAME IS (B)(6) THANK YOU." ON (B)(6) 2024, NURSE ASSIST REACHED OUT TO (B)(6) TO OBTAIN MORE INFORMATION ABOUT THE ADVERSE EVENT. DESCRIPTION FROM THE PHONE CALL: (B)(6) PURCHASED A CASE OF 37-6260 FROM AMAZON BETWEEN JULY TO SEPTEMBER. (B)(6) USED THE BOTTLES FOR IRRIGATING HER HUSBAND'S BILIARY TUBE. HUSBAND EVENTUALLY DIED ON (B)(6) 2023 DUE TO SEPTIC SHOCK. (B)(6) BELIEVES THE 37-6260 BOTTLES THAT WERE USED TO CLEAN HER HUSBAND'S BILIARY TUBES ARE LINKED TO HER HUSBAND'S DEATH. HUSBAND HAD UNDERLYING ILLNESS (CANCER) PRIOR TO USING NURSE ASSIST PRODUCT. (B)(6) USED STERILE SYRINGES TO WITHDRAW THE STERILE WATER IN THE BOTTLES TO IRRIGATE HER HUSBAND'S BILIARY TUBE. (B)(6) WOULD REUSE THE BOTTLES AFTER ITS INITIAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553442 NURSE ASSIST, LLC STERILE WATER FOR IRRIGATION USP IN SCREW BOTTLE TOP FRO NURSE ASSIST, LLC 37-6260 23045199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death