BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.9% SODIUM CHLORIDE BAG

    MDR report key: 18502011 · Received January 12, 2024

    Report

    Report Number
    18502011
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    October 13, 2023
    Report Date
    October 13, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: 100 ML NORMAL SALINE BAG IN MANUFACTURER PACKAGING WAS FOUND WITH A PUNCTURE IN PHARMACY. IT ALSO APPEARED TO BE MORE FULL THAN A NEW 100ML BAG, POSSIBLY INDICATING THAT A SUBSTANCE HAD ALREADY BEEN INJECTED INTO THE BAG. BACKGROUND: ESCALATION FOR FEEDBACK ON NEXT STEPS RE: THIS PRODUCT/LOT NUMBER PER OUR MITIGATION PROCESS FOR MEDICATION RECALLS AND POTENTIALLY ADULTERATED MEDICATION PRODUCTS [REDACTED NAME] HEALTH POLICY. ASSESSMENT/RECOMMENDED: OUR WP11 PHARMACY TEAM IS REVIEWING IF THERE ARE ANY OTHER AFFECTED BAGS IN THE LOT AND HAVE BEEN NOTIFIED TO PAY CLOSE ATTENTION TO DETAIL WHEN PREPARING MEDICATIONS USING THESE BAGS. PHARMACY LEADERSHIP, INFECTION PREVENTION, AND SUPPLY CHAIN ARE BEING NOTIFIED FOR ESCALATION AND ADDITIONAL RECOMMENDATIONS FOR FOLLOW UP. MANUFACTURER RESPONSE FOR IV FLUID BAG OF NORMAL SALINE, (BRAND NOT PROVIDED) (PER SITE REPORTER) IN PROCESS OF NOTIFYING NOW.

    Description of Event or Problem · 0

    SITUATION: 100 ML NORMAL SALINE BAG IN MANUFACTURER PACKAGING WAS FOUND WITH A PUNCTURE IN PHARMACY. IT ALSO APPEARED TO BE MORE FULL THAN A NEW 100ML BAG, POSSIBLY INDICATING THAT A SUBSTANCE HAD ALREADY BEEN INJECTED INTO THE BAG. BACKGROUND: ESCALATION FOR FEEDBACK ON NEXT STEPS RE: THIS PRODUCT/LOT NUMBER PER OUR MITIGATION PROCESS FOR MEDICATION RECALLS AND POTENTIALLY ADULTERATED MEDICATION PRODUCTS (B)(6) POLICY. ASSESSMENT/RECOMMENDED: OUR WP11 PHARMACY TEAM IS REVIEWING IF THERE ARE ANY OTHER AFFECTED BAGS IN THE LOT AND HAVE BEEN NOTIFIED TO PAY CLOSE ATTENTION TO DETAIL WHEN PREPARING MEDICATIONS USING THESE BAGS. PHARMACY LEADERSHIP, INFECTION PREVENTION, AND SUPPLY CHAIN ARE BEING NOTIFIED FOR ESCALATION AND ADDITIONAL RECOMMENDATIONS FOR FOLLOW UP. MANUFACTURER RESPONSE FOR IV FLUID BAG OF NORMAL SALINE, (BRAND NOT PROVIDED) (PER SITE REPORTER), IN PROCESS OF NOTIFYING NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917314 0.9% SODIUM CHLORIDE BAG CONTAINER, I.V. KPE BAXTER HEALTHCARE CORPORATION 2B1307 US015073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown