BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE CLOSED SUCTION CATHETER

    MDR report key: 3840218 · Received May 22, 2014

    Report

    Report Number
    MW5036350
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 21, 2014
    Product Code
    BSY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS INTUBATED WITH AN ENDOTRACHEAL TUBE AFTER BEING A PEDESTRIAN STRUCK BY A MOTOR VEHICLE. IN LINE SUCTION WAS ATTACHED TO THE ETT USING AN AIRLIFE CLOSED SUCTIONING PRODUCT (LOT # 13003472C) AFTER 2-3 DAYS PT WAS INCREASINGLY HYPOXIC, TACHYPNEIC WITH HIGH AIRWAY PRESSURES. SUCTION CATHETER PASSED WELL BUT PT GOT PROGRESSIVELY WORSE. PT ELECTIVELY RE-INTUBATED AND WHEN THE ETT WAS REMOVED, IT WAS DISCOVERED THAT THE TIP OF THE ETT WAS CLOGGED AND THAT THE INLINE SUCTION CATHETER DID NOT REACH THE CLOG BECAUSE THE WRONG CATHETER WAS USED. IN REVIEW, THE INLINE CATHETER USED WAS MEANT TO BE USED ON A TRACHEOSTOMY TUBE NOT AN ETT. PACKAGE REVIEW SHOWS THAT BOTH THE TRACH AND ETT HAVE A PALE PURPLE SUCTION TIP AND ALL PACKAGING IS IDENTICAL EXCEPT FOR SMALL LETTERING THAT IDENTIFIES THE TRACH ONE AS TRACH LENGTH. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: INLINE SUCTION OF TRACHEOSTOMY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304530 AIRLIFE CLOSED SUCTION CATHETER AIRLIFE CLOSED SUCTION CATHETER BSY 13003472C

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R