BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOBBHOFF 12FR 43IN W STYLET EN

    MDR report key: 18100968 · Received November 9, 2023

    Report

    Report Number
    9612030-2023-03853
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    October 4, 2023
    Report Date
    December 19, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNT
    UDI-DI
    10884521582927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS PROVIDED, AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. THE DEVICE WAS MANUFACTURED ON 11-OCT-2021. BASED ON THE INFORMATION AVAILABLE TO US, WE WERE UNABLE TO CONFIRM THE EVENT. IN THE MEANTIME, ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES.

    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 THAT THE PATIENT WAS GIVEN CRUSHED MEDICINES VIA NASOGASTRIC TUBE (NGT), EXISTING NGT WAS BLOCKED, AND IT WAS UNABLE TO UNBLOCK, SO THE TUBE WAS REMOVED. PER CUSTOMER, ATTEMPT WAS MADE TO RE-INSERT A FINE BORE NGT, A RESISTANCE WAS FELT, SO THE INSERTION WAS STOPPED AND REQUESTED HELP FROM ICU DOCTORS. THE ICU DOCTOR TOOK OVER THE NGT INSERTION AND FINE BORE NGT WAS INSERTED, AWAITED CHEST X-RAY (CXR) FOR CONFIRMATION OF PLACEMENT. THE CHEST X-RAY SHOWED THE NGT WAS FAR DOWN PATIENT¿S RIGHT MAIN BRONCHUS, A PNEUMOTHORAX WAS NOTED. THE NGT WAS PULLED RIGHT BACK AND RE-INSERTED SUCCESSFULLY WITH PLACEMENT CONFIRMED ON CHEST X-RAY AND A RIGHT PIGTAIL ICC WAS INSERTED FOR PNEUMOTHORAX..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803587 DOBBHOFF 12FR 43IN W STYLET EN TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 8884711253E 2127804064 10884521582927

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other