BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 114305 · Received August 20, 1997

    Report

    Report Number
    2029387-1997-00122
    Event Type
    Injury
    Date Received
    August 20, 1997
    Date of Event
    May 20, 1997
    Report Date
    July 12, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECARE PT REQUIRED EMERGENCY MEDICAL INTERVENTION TO RE-ESTABLISH AIRWAY WHEN PARENT AND HOMECARE NURSE WERE UNABLE TO REINTUBATE THE PT WITH BACK-UP 5.0PED, PEDIATRIC TRACHEOSTOMY TUBE. DURING THE EVENING, PT REPORTEDLY "PULLED" HIS TRACH OUT. DURING ATTEMPTS TO RE-INTUBATE WITH A BACKUP 5.0PED, PROBLEMS WERE ENCOUNTERED WITH THE OBTURATOR INSERTING/WITHDRAWING SMOOTHLY INTO THE CANNULA. IT WAS ALSO REPORTED THAT THE OBTURATOR DID NOT PROTRUDE THE CANNULA SUFFICIENTLY TO PROVIDE AN ADEQUATE GUIDE FOR THE ATTEMPTED DEVICE INSERTION. PT'S AIRWAY WAS RE-ESTABLISHED WITH USE OF A CATHETER AND THE BACK-UP 5.0PED DEVICE WAS SUCCESSFULLY PLACED. PT RETURNED TO BASELINE CONDITION. IS THE EVENT FREQUENCY 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 Implant TRACHEOSTOMY TUBE JOH MALLINCKRODT MEDICAL, INC. 5.0 PED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6.5 YR Required Intervention