BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 10377279 · Received August 6, 2020

    Report

    Report Number
    3012307300-2020-07912
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 7, 2020
    Report Date
    October 2, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    10351688518699
    PMA / PMN Number
    K923878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THEY HAD TO PERFORM A TRACHEOSTOMY TUBE CHANGE OUT. THEY ONLY HAD ONE TRACH TUBE TO PERFORM THIS WITH. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS. PATIENT INFORMATION UPDATED.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE PICTURE OF THE DEVICE WAS RECEIVED AND ANALYSTS OBSERVED A PART PILOT BALLOON WITH ITS VALVE BUT NO DAMAGE COULD BE DETECTED. ONE (1) SAMPLE WAS RECEIVED FROM P/N 60PFSS40 L/N 3962584 WITHOUT ITS ORIGINAL PACKAGING, IN USED CONDITIONS WITH ITS CERTIFICATE OF DECONTAMINATION. DURING THE VISUAL INSPECTION, WE OBSERVED THAT PILOT BALLOON WAS BROKEN AND SEPARATED FROM THE AIRWAY. ACCORDING TO PFMEA RMD-10001943.100 - ?PFMEA FOR BIVONA TRACHEOSTOMY TUBES.? THE OCCURRENCE FOR THIS FAILURE CONDITION COULD BE CAUSED BY: SUPPLIER MOLDING PROCESS ERROR. INSTRUCTIONS FOR USE WERE REVIEWED ?10018858-001 REV.100 - IFU-FLEXTEND TRACHEOSTOMY.? ON SECTION 4.8 SAYS: ?DO NOT USE A TUBE THAT IS CUT OR DAMAGED. USE OF A DAMAGED TUBE CAN RESULT IN AIRWAY COMPROMISE. THIS DEVICE MUST BE THOROUGHLY INSPECTED FOR SIGNS OF DAMAGE OR WEAR PRIOR TO EACH USE.? ON SECTION 4.10 SAYS: ?GUARD AGAINST PRODUCT DAMAGE BY AVOIDING CONTACT WITH SHARP EDGES. SOME TRACHEOSTOMY TUBE HOLDERS CONTAIN VELCRO OR METAL CLIPS WHICH MAY HAVE SHARP EDGES. THESE SHARP EDGES CAN COME INTO CONTACT WITH THE EYELETS AND COMPROMISE THE PRODUCT INTEGRITY. A DAMAGED EYELET CAN RESULT IN DECANNULATION OF THE TRACHEOSTOMY TUBE. WE RECOMMEND USING THE TWILL TAPE HOLDER SUPPLIED WITH THE PRODUCT.? SEE IMAGE BELOW FOR EVIDENCE: ON SECTION 8.2 SAYS: ?DURING THE CLEANING PROCESS INSPECT THE PRODUCT FOR ANY SIGNS OF DAMAGE. DISCARD THE PRODUCT IF THERE IS ANY SIGN OF DAMAGE?. OCURRENCE: ? PRODUCTION PERSONNEL INSPECTS THE PARTS 100% BEFORE ASSEMBLING THEM TO SEE IF THEY HAVE ANY MOLDING ISSUE SUCH AS VOIDS OR SPLITS. ? AFTER THE PARTS ARE ASSEMBLED PRODUCTION PERSONNEL PERFORMS A 100 % VISUAL INSPECTION TO SEE IF THEY HAVE ANY MOLDING ISSUE SUCH AS EXPOSED WIRE, VOIDS OR SPLITS. DETECTION: ? QUALITY TAKES A REPRESENTATIVE SAMPLE AND PERFORMS A VISUAL INSPECTION FOR SPLITS/CUTS, EXPOSED WIRE ACCORDING TO QP BIVONA TT-FG-TJ REV. 113 ? INSPECTION FOR BIVONA FINISH GOODS. CUSTOMER REPORTED THAT: ?A BRAND NEW TRACH FOR THE PATIENTS SON WAS IN FOR A FEW DAYS WHEN THE PILOT BALLOON DETACHED FROM THE FLANGE AND WAS NO LONGER USABLE.? BASED ON THE ANALYSIS CONDUCTED IN THE SAMPLE PROVIDED, THE FAILURE WAS CONFIRMED. THEREFORE, ACCORDING TO IFU AND PFMEA THE OCCURRENCE OF THIS FAILURE CONDITION COULD BE CAUSED BY: ? CONTACT WITH SHARP EDGES DURING THE USE, THIS DEVICE MUST BE THOROUGHLY INSPECTED FOR SIGN OF DAMAGE OR WEAR PRIOR TO EACH USE. ? SUPPLIER MOLDING PROCESS ERROR FOR THIS OCCURRENCE THE MITIGATION TO DETECT THIS ARE: -RECEIVING INSPECTION TAKES A REPRESENTATIVE SAMPLE PER LOT AND PERFORMS A VISUAL INSPECTION ACCORDING TO MD01-003 TO VERIFY PARS ARE FREE OF DAMAGE AND MOLDING DEFECTS SUCH AS SINKS, SHORT SHOTS, DISTORTION, CRACKING OR CRAZING. -DURING THE MANUFACTURING PROCESS PARTS ARE 100% INSPECTED BEFORE ASSEMBLING THEM TO SEE IF THEY HAVE ANY MOLDING ISSUE SUCH AS VOIDS/SPLITS ACCORDING TO QP BIVONA TT-FG-TJ. ALL MITIGATIONS ON PLACED WERE VERIFIED AND IT WAS CONFIRMED HAS BEEN EXECUTING ACCORDING, THEREFORE NO CORRECTIVE ACTIONS COULD BE IMPLEMENTED, IT WILL BE CONTINUE MONITORING THIS FAILURE CONDITION IN THIS PRODUCT FOR THRESHOLD OR ESCALATION. NO CORRECTIVE ACTIONS WERE TAKEN. HOWEVER, AS PART OF CONTAINMENT, PRODUCTION PERSONNEL WAS NOTIFIED BY QUALITY ENGINEER ON 02/SEPT/2020 AS AWARENESS OF THE DEFECT REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BRAND NEW SMITHS MEDICAL TRACH FOR THE PATIENTS SON WAS IN FOR A FEW DAYS WHEN THE PILOT BALLOON DETACHED FROM THE FLANGE AND WAS NO LONGER USABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836070 BIVONA TRACHEOSTOMY TUBE AND CUFF JOH SMITHS MEDICAL ASD, INC. 67PFSS40 3962584 10351688518699

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention