BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA® UNCUFFED NEONATAL FLEXTEND¿ PLUS V FLANGE TRACHEOSTOMY TUBE

    MDR report key: 6034686 · Received October 17, 2016

    Report

    Report Number
    3012307300-2016-00114
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Report Date
    May 1, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    JOH
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ONE USED BIVONA® UNCUFFED NEONATAL FLEXTEND¿ PLUS V FLANGE TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING AND INSIDE A PLASTIC BAG. A REVIEW OF THE DEVICE HISTORY LOT FOR THE POTENTIAL LOT 2961961 FOUND NO NONCONFORMITIES OR ISSUES DURING MANUFACTURING. VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED AT A DISTANCE OF 12" AND UNDER NORMAL CONDITIONS OF ILLUMINATION. EXAMINATION OBSERVED THAT THE CONNECTOR WAS MARKED WITH NUMBER 8 IN BLACK AND THAT THE SAMPLE HAD A CUT ON THE FLANGE EYELET. THE MANUFACTURING FACILITY ATTEMPTED TO REPLICATE THE DAMAGE BY SELECTING A SIMILAR PRODUCT AND PERFORMING TESTING. THE MANUFACTURING FACILITY WAS ABLE TO INDUCE SIMILAR PHYSICAL DAMAGE BY CREATING A SMALL CUT AT THE EYELET AREA, THREADING THE TUBE TIES THROUGH THE EYELET HOLES AND PULLING ON THE TRACHEOSTOMY TUBE TIES. THE MANUFACTURING FACILITY PERFORMED A REVIEW OF THE MANUFACTURING PROCESS OF A SIMILAR PRODUCT. THE REVIEW SHOWED THAT ASSEMBLY PROCESS WAS BEING PERFORMED AS PER PROCEDURES: THIS INCLUDED REVIEW OF BASIC ASSEMBLY, MANUAL CLEANING, INCOMING INSPECTION AND INSPECTION AFTER ASSEMBLY PROCESSES. THE MANUFACTURING FACILITY ALSO PERFORMED AN IN-PROCESS VISUAL INSPECTION OF 32 PRODUCTS THAT WERE IN THE ASSEMBLY AREA: THIS INSPECTION SHOWED NO MOLDING ISSUES (SHORT SHOTS, SPLITS, VOIDS OR BUBBLING) WITH THE PRODUCTS BEING ASSEMBLED. THE INVESTIGATION CONFIRMED THE PRODUCT HAD SUSTAINED DAMAGE AT THE EYELET AREA. THE INVESTIGATION WAS UNABLE TO DEFINITELY IDENTIFY THE ROOT CAUSE OF THE ISSUE BUT ISOLATED TWO POTENTIAL ROOT CAUSES. THE MANUFACTURER DETERMINED THE ISSUE EITHER OCCURRED DUE TO THE PRODUCT COMING INTO CONTACT WITH A SHARP EDGE DURING USE OR THE FLANGE HAD A MOLDING ISSUE OR CUT THAT WAS PRESENT DURING PRODUCTION BUT NOT DETECTED DURING THE ASSEMBLY PROCESS. HOWEVER, THE MANUFACTURING FACILITY'S REVIEW OF THE MANUFACTURING PROCESS DID NOT IDENTIFY ANY ISSUES. ADDITIONAL 510 NUMBER: K083641. POTENTIAL LOT NUMBER: 2961961. POTENTIAL EXPIRATION DATE: 06/28/2020. POTENTIAL MANUFACTURING DATE: 06/19/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE FLANGE SPLIT WHILE IN USE AT THE PATIENT'S HOME. THE SPLIT IN THE FLANGE RESULTED IN THE TIES BECOMING UNCONNECTED FROM THE TUBE. UPON NOTING THE INCIDENT, THE MOTHER OF THE PATIENT REMOVED THE TRACHEOSTOMY TUBE AND INSERTED A NEW ONE. . THE TRACHEOSTOMY TUBE HAD BEEN IN PLACE FOR 7 DAYS PRIOR TO THE EVENT. THE EVENT OCCURRED DURING A WEEKLY TUBE CHANGE AT THE START OF THE YEAR IN 2016. THE PATIENT COULD NOT BREATHE WITHOUT THE TRACHEOSTOMY TUBE IN PLACE BUT WAS NOT VENTILATOR DEPENDENT. TWILL TAPE AND A MARPAVE TRACHEOSTOMY TUBE HOLDER WERE USED. THE PATIENT UNDERWENT ALTERNATING DAY TAPE CHANGES. NO PERMANENT INJURY OCCURRED. SEE MFR 3012307300-2016-00113, 3012307300-2016-00115, 3012307300-2016-00191.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685196 BIVONA® UNCUFFED NEONATAL FLEXTEND¿ PLUS V FLANGE TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC

    Patients

    Seq Age Sex Outcome Treatment
    1