BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA

    MDR report key: 10834459 · Received November 13, 2020

    Report

    Report Number
    3012307300-2020-11422
    Event Type
    Injury
    Date Received
    November 13, 2020
    Report Date
    December 10, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312516791
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS . PICTURE WAS RECEIVED, WHICH OBSERVED A SPLIT ON THE CORNER OF THE FLANGE. ACCORDING TO PFMEA 10018858-001 REV.100 - IFU-FLEXTEND TRACHEOSTOMY THE OCCURRENCE FOR BROKEN NECKSTRAP CONDITION COULD BE CAUSED BY: SUPPLIER PROCESS RELATED. INSTRUCTIONS FOR USE WERE REVIEWED ?10018858-001 REV.100 - IFU-FLEXTEND TRACHEOSTOMY. ON SECTION 4.8 STATES: 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. ENGINEERING AND OCCURRENCE REVIEWED WHICH PERFORMED 100% PRIOR TO RELEASE OF PRODUCT. NO CORRECTIVE ACTIONS WERE TAKEN. HOWEVER, AS PART OF CONTAINMENT, PRODUCTION PERSONNEL WAS NOTIFIED BY QUALITY ENGINEER ON (B)(6) 2020 AS AWARENESS OF THE DEFECT REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS . PICTURE WAS RECEIVED, WHICH OBSERVED A SPLIT ON THE CORNER OF THE FLANGE. ACCORDING TO PFMEA 10018858-001 REV.100 - IFU-FLEXTEND TRACHEOSTOMY THE OCCURRENCE FOR BROKEN NECKSTRAP CONDITION COULD BE CAUSED BY: SUPPLIER PROCESS RELATED. INSTRUCTIONS FOR USE WERE REVIEWED 10018858-001 REV.100 - IFU-FLEXTEND TRACHEOSTOMY. ON SECTION 4.8 STATES: 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. ENGINEERING AND OCCURRENCE REVIEWED WHICH PERFORMED 100% PRIOR TO RELEASE OF PRODUCT. NO CORRECTIVE ACTIONS WERE TAKEN. HOWEVER, AS PART OF CONTAINMENT, PRODUCTION PERSONNEL WAS NOTIFIED BY QUALITY ENGINEER ON (B)(6) 2020 AS AWARENESS OF THE DEFECT REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMITHS MEDICAL TRACH TUBE GOT DISLODGE THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302799 BIVONA TRACHEOSTOMY TUBE AND CUFF JOH SMITHS MEDICAL ASD, INC. 60PFSS45 15021312516791

    Patients

    Seq Age Sex Outcome Treatment
    1