BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 210985 · Received February 18, 1999

    Report

    Report Number
    2029387-1998-00167
    Event Type
    Injury
    Date Received
    February 18, 1999
    Date of Event
    September 3, 1996
    Report Date
    December 23, 1998
    Manufacturer
    MALLINCKRODT MEDICAL INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECARE PT EXPERIENCED DISTRESS, TRAUMA AND REQUIRED MEDICAL INTERVENTION AND HOSPITALIZATION AS A RESULT OF BEING INTUBATED WITH AN INCORECT MODEL/SIZE TRACHEOSTOMY TUBE. THE PT REQUIRED A SIZE 0 NT, NEONATAL TRACHEOSTOMY TUBE AND WAS REPORTEDLY INTUBATED WITH A SIZE 0 PT, PEDIATRIC TRACHEOSTOMY TUBE. IT IS UNK HOW LONG THE DEVICE WAS IN USE, WHO PERFORMED THE DEVICE INTUBATION, WHAT TYPE OF DEVICE USAGE, CARE AND MAINTENANCE WAS PERFORMED. LIMITED INFO REGARDING THE EVENT, DIAGNOSED TREATMENT(S), DEVICE USAGE AND INVOLVED PERSONNEL WAS PROVIDED BY THE PRODUCT LIABILITY MANAGEMENT COMPANY WHO REPORTED THIS EVENT TO THE DEVICE MFR. THE ONLY EVENT INFO RECEIVED BY THE DEVICE MFR. THE ONLY EVENT INFO RECEIVED BY THE DEVICE MFR ALLEGES THAT THE SIZE 0 PT DEVICE WAS PACKAGED/LABELED AS 0 NT DEVICE AND THAT C-P MEDICAL PRODUCTS INC. DISPENSED A DEVICE PACKAGED/LABELED AS 0 NT TO THE PT'S HOME/HOMECARE ATTENDANT(S). THE STATUS/AVAILABILITY OF THE INVOLVED 0 PT DEVICE, THE 0 NT DEVICE PACKAGING AND ASSOCIATED IDENTIFICATION (LOT NUMBERS ETC) REMAIN UNK. BASED ON THE KNOWN INFO REGARDING THIS EVENT THERE WAS NO REPORTED DEVICE MALFUNCTION AND/OR BREAKAGE ASSOCIATED WITH THE DEVICE. IN ADDITION, THERE WAS NO REPORTED PROBLEMS OR DIFFICULTIES ENCOUNTERED DURING DEVICE INTUBATION. A DESIGN, MATERIAL AND DIMENSIONAL ANALYSIS OF THE SIZE 0 NT AND SIZE 0 PT DEVICES SHOW THAT BOTH THESE DEVICES ARE MFG WITH THE SAME INNER AND OUTER CANNULA TUBING DIAMETERS AND THE SAME CANNULA TUBING ARC ANGLES. THE 0 NT DEVICE HAS A SHORTER CANNULA TUBE AND NECK FLANGE THAN THE 0 PT DEVICE WHICH IS VISUALLY APPARENT UPON REMOVAL FROM THE DEVICE PACKAGING DURING THE PROCEDURE SET-UP. THERE WAS ONE (1) PT INVOLVED WHO RETURNED TO BASELINE CONDITION, WAS RELEASED FROM THE HOSPITAL ONE DAY AFTER ADMITTANCE WITH NO LONG TERM EFFECTS AS A RESULT OF THE REPORTED EVENT. THE INFO CONTAINED IN THIS REPORT HAS BEEN SOLELY PROVIDED BY THE PRODUCT LIABILITY MANAGEMENT COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PEDIATRIC TRACHEOSTOMY TUBE Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL INC. 0 PT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R