BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8FR CORFLO ULTRA LITE NON WT NASOGASTRIC TUBE

    MDR report key: 4173157 · Received September 18, 2014

    Report

    Report Number
    3009124963-2014-00026
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 17, 2014
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE MEDWATCH REPORT RECEIVED FROM THE CUSTOMER IDENTIFIED THE FEEDING TUBE USED DURING THE EVENT WAS A CORTRAK NASOGASTRIC TUBE (B)(4). AFTER DISCUSSING THE EVENT DETAILS WITH THE RISK MANAGER, IT WAS CONFIRMED THAT THE FEEDING TUBE USED DURING THE EVENT WAS AN 8 FR CORFLO ULTRA NASOGASTRIC FEEDING TUBE (B)(4). THE LOT NUMBER IS UNKNOWN. IT IS UNCLEAR IF THE FEEDING TUBE WAS INSERTED NASALLY OR ORALLY AND HOW THE PERFORATION OCCURRED. DUE TO THE INFANT'S SIZE, FRAILTY AND PREMATURITY THE POSSIBILITY FOR PERFORATION MAY HAVE BEEN INCREASED. THE INSTRUCTIONS FOR USE PROVIDE SPECIFIC MEASUREMENTS TO APPLY AND STATES NOT TO INSERT EXCESS TUBING. WITHOUT THE SAMPLE AND ADDITIONAL INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE.

    Description of Event or Problem · 1

    AN 8FR NASOGASTRIC FEEDING TUBE WAS PLACED IN A ONE MONTH OLD PREMATURE INFANT. THERE WERE NO DIFFICULTIES DURING PLACEMENT HOWEVER 5 DAYS AFTER PLACEMENT A BOWEL PERFORATION WAS VERIFIED BY RADIOLOGY. SURGERY WAS PERFORMED TO CORRECT THE PERFORATION. THE INFANT IS CURRENTLY STABLE IN THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579232 8FR CORFLO ULTRA LITE NON WT NASOGASTRIC TUBE FEEDING TUBE KNT CORPAK MEDSYSTEMS 20-9368 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other