BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 112597 · Received August 11, 1997

    Report

    Report Number
    2029387-1997-00101
    Event Type
    Malfunction
    Date Received
    August 11, 1997
    Date of Event
    April 1, 1997
    Report Date
    June 18, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: THE MFR'S ANALYSIS AND EVALUATION OF THE RETURNED 5.0PED DEVICE COULD NOT CONFIRM THE RPT'D CONNECTION NON-CONFORMANCE. A DIMENSIONAL INSPECTION OF THE OUTER DIAMETER ON THE CONNECTOR AND THE SWIVEL CONNECTOR WAS PERFORMED WITH ACCEPTABLE RESULTS. ALTHOUGH CO WAS UNABLE TO DUPLICATE OR DETERMINE THE EXACT CAUSES OF THE RPT'D PROBLEM, IT APPEARS THAT THE SWIVEL CONNECTOR IS WORN AND THIS MAY BE CONTRIBUTING TO THE RPT'D PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO INTL. MM GMBH FACILITY (GERMANY) THAT A SECURE CONNECTION COULD NOT BE MAINTAINED BETWEEN THE VENTILATOR SWIVEL CONNECTOR AND THE 15MM CONNECTOR ON A 5.0 PED, PEDIATRIC TRACHEOSTOMY TUBE. THE REPORTED DISCONNECTION WAS DETECTED WITHIN A FEW HOURS AFTER ATTACHMENT. THERE WAS NO REPORTED PT INJURY. LIMITED INFO AVAILABLE REGARDING DEVICE USAGE, MAINTENANCE OR CONCOMITANT PRODUCTS INVOLVED (RESPIRATORY ADAPTOR(S), CONNECTORS ETC.). THE 5.0PED DEVICE WAS RETURNED TO THE MFR ON 5/24/97 FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION. IS THE EVENT FREQUENCEY ADDRESSED IN PRODUCT LABELING? NO. IF "NO, IS EVENT OCCURRING MORE FREQUENTLY THAN USUAL FOR PRODUCT? NO. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "NO", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCTIONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PEDIATRIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH MALLINCKRODT MEDICAL, INC. 5.0 PED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN