BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 5521235 · Received March 23, 2016

    Report

    Report Number
    2183502-2016-00602
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    February 22, 2016
    Report Date
    March 23, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K912469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETED (07/07/2016): EVALUATION RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. THE EXAMINATION OF THE RETURNED DEVICE SHOWED THE SAMPLE WAS PINCHED AT THE DISTAL END. THE SILICONE WAS CRACKED AND THE SPRING COIL WAS DISTORTED AND PARTIALLY EXPOSED AT VARIOUS POINTS. VISUAL INSPECTION DID NOT REVEAL ANY CRACKS IN THE SILICONE ON THE INSIDE OF THE SHAFT. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER (2113269) HAS BEEN REVIEWED; THIS REVIEW SHOWED NO DEVIATIONS OR ABNORMALITIES RELATED TO THE REPORTED ISSUE. THE MANUFACTURING FACILITY PERFORMED AN AUDIT OF THE MOLDING AND ASSEMBLY AREA: THIS REVIEW DID NOT IDENTIFY ANY CONDITIONS THAT COULD PRODUCE THE DAMAGE SEEN ON THE RETURNED SAMPLE. THE MANUFACTURING PROCESS FOR THIS DEVICE INCLUDES SEVERAL INSPECTIONS THAT WOULD DETECT THIS TYPE OF DAMAGE AND REJECT THE PRODUCT HAD THE DAMAGE BEEN PRESENT AT THAT TIME. IN ADDITION, THE MOLDING AND ASSEMBLY AREA PERFORMS A KINK TEST FOR EACH TUBE SHAFT FOR 100% OF THESE PRODUCTS. THE INVESTIGATION DETERMINED THE DAMAGE TO THE SAMPLE WOULD HAVE OCCURRED AFTER MANUFACTURING. INVESTIGATION COULD NOT DETERMINE THE ROOT CAUSE OF THE BROKEN SHAFT; HOWEVER, NO EVIDENCE WAS FOUND TO SUGGEST AN INTRINSIC MANUFACTURING DEFECT.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTS ON BEHALF OF THE USER FACILITY THAT THE DEVICE WAS IN USE WITH PATIENT FOR 5 DAYS. ACCORDING TO REPORTER, THE ATTACHED VENTILATOR GAVE AN ALARM. A TUBE CHANGE WAS PERFORMED WITH NO ADVERSE EFFECTS TO PATIENT REPORTED. EXAMINATION OF THE REMOVED PRODUCT SHOWED DAMAGE TO THE TUBE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175389 BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA 2113269

    Patients

    Seq Age Sex Outcome Treatment
    1