BEUDAMED
    FDA Adverse Event Death Summary report: N

    SALEM SUMP

    MDR report key: 22709105 · Received August 4, 2025

    Report

    Report Number
    1423537-2025-00300
    Event Type
    Death
    Date Received
    August 4, 2025
    Report Date
    October 15, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    PIF
    UDI-DI
    10884521779457
    PMA / PMN Number
    K190923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. A DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE INVOLVED PRODUCT COULD NOT BE EVALUATED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. SECTION D2A PRODUCT CODE (SECONDARY CODE): FEG, TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION. SECTION H6 HEALTH EFFECT - CLINICAL CODE, APPROPRIATE CLINICAL SIGNS, SYMPTOMS AND CONDITIONS TERM/CODE NOT AVAILABLE: CARDIOPULMONARY ARREST.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INSERTION ON (B)(6) 2025 OF A NASOGASTRIC TUBE ON A PATIENT WHO WAS POORLY RELIEVED. THE PATIENT WAS TRANSFERRED TO IMAGING FOR A CT SCAN TO IDENTIFY THE CAUSE OF THE OCCLUSION. PERSISTENCE OF VOMITING ON CT SCAN WITH MASSIVE INHALATION RESPONSIBLE FOR CARDIOPULMONARY ARREST NOT RECOVERED IN RADIOLOGY. IN ALL LIKELIHOOD, THE SUCTION OF THE NASOGASTRIC TUBE WAS UNSATISFACTORY DUE TO THE LACK OF OPENING OF THE AIR INTAKE SYSTEM. INDEED, IN THE ABSENCE OF AN ANTI-BACKFLOW VALVE, THE ENFIT CONNECTOR HAS BEEN CONNECTED TO THE PROBE, WITH THE CAP CLOSED. CURRENT PATIENT CONDITION: ABSENCE OF SUCTION FOR SEVERAL HOURS. CARDIOPULMONARY ARREST FOLLOWED BY THE PATIENT'S DEATH. ON (B)(6) 2025, (B)(6) CARDINAL HEALTH SALES REP, REPORTED SHE HAD A DISCUSSION WITH CUSTOMER, (B)(6), HEAD NURSE AND CONFIRMED THERE WERE NO PROBLEMS WITH THE DEVICE. INSTEAD, THERE WAS A LACK OF KNOWLEDGE ON THE PART OF SOME CAREGIVERS. ADDITIONAL PRODUCT TRAINING WILL BE PROVIDED BY CARDINAL HEALTH SALES TEAM. THE SALES REP ALSO STATED THAT THE CAPPED ENFIT WAS IN THE BLUE PORT. THE FACILITY DID NOT HAVE ACTIVE SUCTION HOOKED UP TO THE CLEAR PART OF THE TUBE. THEY HAD GOTTEN RETURN OF STOMACH CONTENTS FROM THIS TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2527894 SALEM SUMP GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF CARDINAL HEALTH, INC. 8888264986E 10884521779457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death