BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERIOR SUCTION CATHETER KIT

    MDR report key: 16763 · Received September 1, 1994

    Report

    Report Number
    16763
    Event Type
    Malfunction
    Date Received
    September 1, 1994
    Date of Event
    February 11, 1994
    Report Date
    March 11, 1994
    Manufacturer
    SUPERIOR HEALTHCARE GROUP, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECENTLY SWITCHED TO CITED PRODUCT WHEN PRIOR EQUIVALENT BECAME UNAVAILABLE. SINCE THAT CHANGE, DURING 2/94, 3 PATIENTS HAVE, FOLLOW SUCTIONING PROCEDURES, DEVELOPED HEMOPTYSIS & BLOODY AIRWAY SECRETIONS. BRONCHOSCOPY ON ONE PATIENT SHOWED EVIDENCE OF TRACHEOBRONCHIAL TRAUMA ACCORDING TO THE PHYSICIAN. ALTHOUGH TECHNIQUE HAS BEEN QUESTIONED AS A CONTRIBUTING FACTOR (AND INSERVICE INSTITUTED), THERE HAS BEEN NO HISTORY OF SIMILAR EVENTS/PATTERNS OF EVENTS PRIOR TO THE PRODUCT CHANGE. PATIENT FACTORS PROBABLY ALSO CONTRIBUTED SINCE EACH CASE WAS COMPLEX (HAVING BEEN INTUBATED, TWO ON VENTILATORS, ET CETERA). NONE REQUIRED SIGNIFICANT INTERVENTION AND ALL WERE DISCHARGED ALIVE. THE SUSPECT DEVICE HAS BEEN REPLACED AND, TO DATE, NO FURTHER SUCH EVENTS HAVE OCCURRED. THERE WERE, ON EXAMINATION, NO OBVIOUS PROBLEMS/DEFECTS IN THE CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERIOR SUCTION CATHETER KIT 14 FR. SUCTION CATHETER BSY SUPERIOR HEALTHCARE GROUP, INC. 4006B

    Patients

    Seq Age Sex Outcome Treatment
    1 41 * Other TRACHEOSTOMY (2 PATIENTS)| ENDOTRACHEAL INTUBATION (3 PATIENTS)| MECHANICAL VENTILATION (2 PATIENTS)