BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 112997 · Received August 15, 1997

    Report

    Report Number
    1217052-1997-00035
    Event Type
    Injury
    Date Received
    August 15, 1997
    Date of Event
    July 6, 1997
    Report Date
    July 17, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: EVALUATION: SIMS REC'D ADDITIONAL INFO REGARDING THIS EVENT FROM THE ATTACHED VOLUNTARY MEDWATCH FORM. THIS FROM PROVIDED LOT NUMBER IDENTIFICATION. SIMS REVIEW OF CO'S COMPLIANT DATABASE REVEALS NO SIMILAR REPORTS OF PROBLEMS WITH THIS MFG LOT NUMBER FROM ANY OTHER USER FACILITY. SIMS HAS DETERMINED THAT THE VENTILATORY OBSTRUCTION BEING CAUSED BY A POSSIBLE FALSE TRACT AS LISTED ON THE USER REPORT IS UNLIKELY. CO REACHED THIS CONCLUSION BECAUSE AN OBSTRUCTION CAUSED BY A FALSE TRACT WOULD LIKELY CAUSE PT COMPLICATIONS IMMEDIATELY AFTER PLACEMENT WHEREAS THIS PT EXPERIENCED PROBLEMS 3 DAYS POST INTUBATION.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE TRACHEOSTOMY TUBE TWISTED INSIDE THE PATIENT AND MAY HAVE OCCLUDED. THE PATIENT EXPERIENCED A CORONARY ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIATRIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO SMITHS INDUSTRIES MEDICAL SYSTEMS, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening