BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRACARE ULTRAFLO

    MDR report key: 1602 · Received November 3, 1992

    Report

    Report Number
    1819504-1992-00001
    Event Type
    Injury
    Date Received
    November 3, 1992
    Report Date
    October 30, 1992
    Manufacturer
    ENTECH, INC.
    Product Code
    BSS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SURGICAL ICU COORDINATOR RELAYS 2 PATIENT INCIDENTS WHEN ENTRACARE ULTRAFLO NASOGASTRIC FEEDING TUBE WENT THROUGH TRACHEA AND PUNCTURED LUNGS REQUIRING CHEST TUBE INSERTION TO RESOLVE PNEUMOTHORACES WHICH EXTENDED PATIENT STAY. BOTH PATIENTS ARE REPORTED TO BE RECOVERING. ONE PATIENT HAD A TRACHEOSTOMY. SECOND PATIENT WAS ON A FLOOR-NOT IN ICU- AND WAS NOT ORALLY OR NASALLY INTUBATED BUT MAY HAVE HAD A TRACHEOSTOMY. NURSES WERE ATTEMPTING INSERTION WHEN BOTH INCIDENCES OCCURRED. THE DEVICES WERE DISCARDED AND ARE NOT AVAILABLE FOR EVALUATION. NO OTHER DETAILS ARE AVAILABLEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE DISCARDED, DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Description of Event or Problem · 1

    UPDATED INFORMATION REPORTS THAT THE FIRST PATIENT WAS A 43 YEAR OLD FEMALE WITH A PREEXISTING DIAGNOSIS OF MULTIPLE TRAUMA FROM A MOTOR VEHICLE ACCIDENT RESULTING IN A C6 - C7 FRACTURE AND PARAPLEGIA. AFTER AN ATTEMPT AT TUBE PLACEMENT, A CHEST X-RAY REVEALED PLACEMENT OF THE TUBE IN THE RIGHT MAINSTEM BRONCHUS. THE SECOND PATIENT WAS A 73 YEAR OLD MALE WHO HAD EXPERIENCED A GUN SHOT WOUND TO THE LEFT LOWER CHEST. THE PATIENT HAD UNDERGONE AN EXPLORATORY LAPAROTOMY WITH A LEFT NEPHRECTOMY, SPLEENECTOMY, AND EXPLORATION OF THE ABDOMINAL AORTA AND INFERIOR VENA CAVA. FOLLOWING PASSAGE OF THE TUBE ON 9/7/92, A CHEST X-RAY REVEALED THE TUBE TO BE IN THE PLEURAL SPACE INTO THE COSTOPHRENIC ANGLEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRACARE ULTRAFLO NASOGASTRIC FEEDING TUBE BSS ENTECH, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention