BEUDAMED
    FDA Adverse Event Death Summary report: N

    DBD-SYRINGE, STERILE, FIELD FLUSH 10 ML

    MDR report key: 18514913 · Received January 15, 2024

    Report

    Report Number
    1417592-2024-00027
    Event Type
    Death
    Date Received
    January 15, 2024
    Date of Event
    October 3, 2022
    Report Date
    January 15, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    NGT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUPPLIER, NURSE ASSIST, PROVIDED ADDITIONAL INFORMATION CLARIFYING THAT ITEM UNDER LOT 22073679 IS NOT MEDLINE FLUSH SALINE SYRINGE EMZ10091240 BUT RATHER PN 6240, 100ML BOTTLE OF SALINE, WITH STERICARE BRANDING. CONFIRMATION PROVIDED BY NURSE ASSIST.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER CONTACT THAT ON (B)(6) 2022, "MY MOTHER PASSED AWAY FROM THE UNSTERILE MEDLINE SALINE PRODUCTS USED FOR MONTHS LEADING UP TO HER DEATH RECALLED FROM THE NURSE ASSIST REPORT ON 2023. HAD ALL THE LIFE THREATENING AFFECTS ASSOCIATED WITH THE REPORT." AFTER FURTHER INVESTIGATION IT WAS DETERMINED THAT BASED ON THE MATERIAL AND DATA PROVIDED (STERILIZATION DATA AND FMEA), THERE WAS NOT CONCLUSIVE EVIDENCE THAT THIS DEVICE CAUSED THE PATIENT TO EXPIRE. THE DEVICE WAS NOT AVAILABLE FOR RETURN EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY. THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 0

    "UNSTERILE MEDLINE SALINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726658 DBD-SYRINGE, STERILE, FIELD FLUSH 10 ML NGT MEDLINE INDUSTRIES LP 22073679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death