BEUDAMED
    FDA Adverse Event Summary report: N

    14 FR SHEATHED CATHETER

    MDR report key: 1918772 · Received December 9, 2010

    Report

    Report Number
    2050001-2010-00007
    Date Received
    December 9, 2010
    Date of Event
    November 10, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CAREFUSION
    Product Code
    OFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED FOR EVALUATION; THEREFORE, WE ARE UNABLE TO DETERMINE THE EXACT ROOT CAUSE FOR THE ISSUE REPORTED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER DETAILS FROM THE END USER CUSTOMER IN REGARDS TO THIS REPORTED INCIDENT, BUT AS OF TODAY NO DETAILS HAVE BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER REPORTED WAS REVIEWED AND NO DEVIATIONS WERE FOUND. THEREFORE, BASED ON THE LIMITED INFORMATION AND NO SAMPLES RECEIVED, A ROOT CAUSE FOR THIS REPORTED INCIDENT IS CURRENTLY UNKNOWN, BUT THE PRELIMINARY INVESTIGATION INDICATES A POTENTIAL USER MISUSE THAT COULD BE CAUSED BY INSERTING THE CATHETER BEYOND THE ENDOTRACHEAL TUBE OR BY THE USE OF HIGH VACUUM PRESSURE. BOTH FAILURES WOULD BE CONSIDERED MISUSE AND OFF LABEL.

    Description of Event or Problem · 1

    ONLY LIMITED INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER - THE CUSTOMER REPORTED THAT HE HAS EXPERIENCED BETWEEN 4-6 INCIDENTS IN WHICH THE PATIENT SUSTAINED INTERNAL BLEEDING DURING ENDOTRACHEAL SUCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14 FR SHEATHED CATHETER 14 FR SHEATHED CATHETER OFR CAREFUSION CSC114 09030049

    Patients

    Seq Age Sex Outcome Treatment
    1 Other