BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 1728840 · Received June 14, 2010

    Report

    Report Number
    2183502-2010-00239
    Event Type
    Injury
    Date Received
    June 14, 2010
    Date of Event
    March 28, 2010
    Report Date
    May 11, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A VOLUNTARY REPORT WAS RECEIVED VIA THE US MAIL. THE COVER PAGE FOR THE REPORT STATED: (B)(4), WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. WE ARE FORWARDING IT TO YOU FOR REVIEW SINCE YOU MIGHT BE UNAWARE OF THIS EVENT. THE REPORT CONTAINS ALL THE INFO PRESENTLY AVAILABLE.

    Description of Event or Problem · 1

    RECEIVED NOTICE FROM FDA REGARDING AN INCIDENT. NO USER FACILITY INFO WAS INCLUDED WITH THE NOTICE. EVENT DESCRIPTION IS AS FOLLOWS: EVENT DESCRIPTION (85): VOLUN 23-APR-2010: PT HAS TRACHEOSTOMY AND #5.5 BIVONA PEDIATRIC CUFFED TRACHS ARE PRESCRIBED. CLIENT HAS RECEIVED A TOTAL OF FOUR DEFECTIVE TRACHS FROM DME PROVIDER, PEDIATRIC SPECIALISTS WITH THE LOT# 1565140. TRACH CUFF DOES NOT PROPERLY INFLATE. ONLY ONE SIDE OF CUFF WILL INFLATE. PT'S MOTHER PROVIDED AN UNSCHEDULED TRACH CHANGE IN THE HOME ON (B) (6) 2010, DUE TO PT HAD AN INCREASED WORK OF BREATHING AND INCREASED CONGESTION. UPON REMOVAL OF EXISTING TRACH, IT WAS FOUND THAT CUFF WAS NOT INFLATED ON ONE SIDE. MOTHER REPLACED TRACH WITH A SANITIZED 5.5 BIVONA PEDIATRIC TRACH THAT WAS AVAILABLE IN THE HOME FOR RE-USE WITH A CUFF THAT PROPERLY INFLATED. CLIENT'S RESPIRATORY STATUS WAS PROMPTLY STABILIZED AFTER TRACH CHANGE. DURABLE MEDICAL EQUIPMENT PROVIDER. PEDIATRIC SPECIALISTS WAS NOTIFIED OF INITIAL DEFECT. SINCE THAT DATE PT HAS BEEN DELIVERED -4- #5.5 BIVONA PEDIATRIC TRACHS THAT HAD THE SAME DEFECT WITH THE CUFF. THE DEFECTIVE TRACHS WERE CHECKED FOR PROPER CUFF INFLATION AND WERE NOT USED DUE TO CONTINUED DEFECT. PEDIATRIC SPECIALISTS WAS PROMPTLY NOTIFIED OF EACH DEFECTIVE TRACH RECEIVED. ORIGINAL DEFECTIVE TRACH WAS SENT BACK TO PEDIATRIC SPECIALISTS WHO CONFIRMED DEFECT AS WELL. DME PROVIDER REPORTED THAT FDA REPORTING WOULD ALSO BE SUBMITTED. DATES OF USE: 5 DAYS BEST ESTIMATE: (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: WERDNIG-HOFFMAN SYNDROME - SPINAL MUSCULAR ATROPHY- RESPIRATORY FAILURE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. UNK 1565140

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK