BEUDAMED
    FDA Adverse Event Death Summary report: N

    1180264523 14CH PUR SALEM W/CAP SYSTX25

    MDR report key: 18355309 · Received December 19, 2023

    Report

    Report Number
    9611018-2023-00636
    Event Type
    Death
    Date Received
    December 19, 2023
    Date of Event
    November 26, 2023
    Report Date
    February 23, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE COMPLETED BECAUSE A LOT NUMBER WAS NOT AVAILABLE. NO SAMPLE WAS RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. THE REPORTED CONDITION COULD NOT BE CONFIRMED. WHEN THE COMPLAINT WAS INITIALLY RECEIVED, A REVIEW WAS COMPLETED OF ALL PRODUCTS IN THE MANUFACTURING SITE TO ENSURE THE X-RAY LINE WAS PRESENT, AND ALL MARKS WERE PRESENT ON ALL CATHETERS. A QUALITY ALERT WAS ISSUED TO THE MANUFACTURING LINE, AND COMMUNICATION SESSIONS HELD, TO ENSURE ALL EMPLOYEES ARE AWARE OF THE COMPLAINT AND THE SERIOUSNESS OF THIS REPORT. AT THIS TIME A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WILL NOT BE INITIATED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THE LOT NUMBERS RETURNED FOR EVALUATION SHOWING ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. NINE REPRESENTATIVE SAMPLES WERE RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION. ALL NINE SAMPLES WERE UNOPENED AND UNUSED. THE SAMPLES WERE FROM DIFFERENT LOT NUMBERS AND DIFFERENT CH SIZES. ALL NINE SAMPLES WERE VISUALLY INSPECTED, AND ALL THE SAMPLES HAD ALL THEIR MARKINGS ON THEM. THE COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE PROBE IS NOT RADIOPAQUE ENOUGH AND LACKS CENTIMETER MARKINGS TO BETTER IDENTIFY THE POSITIONING OF THE PROBE. ON NOVEMBER 26, 2023, THE IDE ISSUED AN NSE AT THE REQUEST OF THE INTERNAL. SHE CHECKED THE CORRECT POSITION BY AUSCULTATION AND HAD IT CONFIRMED BY AN X-RAY ACCORDING TO THE SERVICE PROTOCOL. THE INTERN WAS NOT SURE IF HE WOULD SEE THE NGS ON THE X-RAY, BUT DID START ENTERAL FEEDING ON THE INITIAL AUSCULTATION. IN THE END, THE TUBE WAS NOT IN PLACE; IT WAS IN THE TRACHEA. THE PATIENT INHALED HEAVILY, WAS COMPLICATED BY ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) (SEDATION-CURARIZATION-DV) AND THE TREATMENT WAS STOPPED ON (B)(6) 2023. THE PATIENT DIED. THE CUSTOMER REPORTED THE INCIDENT IS RELATED TO A SUPPLY DISRUPTION OF ANOTHER MEDICAL DEVICE. VEA PATIENT, MALE, 65 YEARS OLD, 72KG. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER TO DETERMINE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350169 1180264523 14CH PUR SALEM W/CAP SYSTX25 TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION FEG CARDINAL HEALTH 1180264523

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death