BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK RETROGRADE INTUBATION SET

    MDR report key: 3100266 · Received April 24, 2013

    Report

    Report Number
    1820334-2013-00191
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    COOK, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    (B)(6) FEMALE PRESENTED WITH DIFFICULT AIRWAY SITUATION IN ICU. PHYSICIAN ATTEMPTED DIFFICULT INTUBATION AND WAS UNSUCCESSFUL. ANESTHESIA WAS ATTEMPTED AND MULTIPLE INTUBATION WITH FAILURE. THE PHYSICIAN USED THE COOK RETROGRADE INTUBATION SET AS PER IFU. HE TOLD THE REP THAT HE HAD DIFFICULTY PASSING THE WIRE THROUGH THE ANGIOCATH NEEDLE. THE DOCTOR THINKS THAT THE NEEDLE BENT OR KINKED. THE DOCTOR HAD TO PERFORM AN EMERGENCY TRACHEOSTOMY TO SECURE THE AIR WAY. THE PATIENT OUTCOME WAS POSITIVE, NO MORBIDITY OR MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176717 COOK RETROGRADE INTUBATION SET KRA CATHETER, CONTINUOUS FLUSH KRA COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other