BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE - BIVONA TUBES NEO/PED

    MDR report key: 12657898 · Received October 19, 2021

    Report

    Report Number
    3012307300-2021-10084
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 4, 2021
    Report Date
    May 12, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312000375
    PMA / PMN Number
    K912469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THREE UNITS WERE RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD NOT BE DUPLICATED. DHR REVIEW WAS DONE, NO ISSUES RELATED TO THE ORIGINAL COMPLAINT WERE FOUND. CORRECTED DATA: TWO DIFFERENT LOT NUMBERS 3911420 AND 4056229

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEM OR ISSUES WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW. THREE SAMPLES WERE RECEIVED FOR EVALUATION. THE SAMPLES WERE RECEIVED INN USED CONDITIONS, WITHOUT ITS ORIGINAL PACKAGING AND WITH ITS CERTIFICATE OF SAFE HANDLING. DURING VISUAL INSPECTION, THE SAMPLE WAS VISUALLY INSPECTED UNDER NORMAL CONDITIONS OF ILLUMINATION, IT WAS OBSERVED ONE FLANGE WAS BROKEN. THE FAILURE IS CONFIRMED. THE BROKEN COMPONENTS WERE INSPECTED USING A DIGITAL MICROSCOPE WITH A SCALE OF 30X, TO OBSERVE BETTER THE SHAPE OF THE RUPTURE IN BOTH COMPONENTS. SAMPLE 1: THE CUT IS CLEAN; NO FLASH IS OBSERVED IN THE PERIPHERY. SAMPLE 2: NO FLANGE BROKEN. SAMPLE 3: THE SHAPE IS CLEAN; NO FLASH WAS OBSERVED IN THE PERIPHERY. CONTINUING WITH THE ANALYSIS, WE TRIED TO REPLICATE THE FAILURE REPORTED. DURING NECK STRAP MOLDING PROCESS, IT WAS TRIED TO REMOVE THE UNIT FROM MOLD BUT BUSHING WAS STUCK IT, THEREFORE, WHEN IT WAS TRIED TO REMOVE IT, A SPLIT WAS CREATED WITH THE MOLD IN THE NECK STRAP. THE SPLIT IS LARGE AND DEPT TO THE TUBE. BASED ON THE TEST PERFORMED, IT IS CONCLUDED THAT FAILURE REPORTED COULD NOT BE REPRODUCED DURING THE MOLDING PROCESS SINCE THE CUT CREATED IS NOT IN THE SAME POSITION AS SAMPLE RECEIVED, THE REPRODUCED CUT IS DEEPER THAN CUT FROM SAMPLE RECEIVED. ADDITIONAL ANALYSIS WAS CONDUCTED, WHICH CONSISTED OF A REVIEW THE INSTRUCTIONS FOR USE THAT ARE INCLUDED IN THE DEVICE, BECAUSE THESE INSTRUCTIONS CONTAIN IMPORTANT INFORMATION FOR SAFE USE OF THE PRODUCT, AS WELL AS WARNING AND CAUTIONS TO AVOID DAMAGE DURING THE USE. THE INSTRUCTIONS FOR USE 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 MEET 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. BASED ON INSTRUCTIONS FOR USE, NECK STRAPS COULD BE DAMAGED BY CONTACT WITH SHARP EDGES FROM TRACHEOSTOMY HOLDERS. THEREFORE, IT IS RECOMMENDABLE USE THE TWILL TAPE HOLDER SUPPLIED WITH THE PRODUCT. MOST PROBABLE ROOT CAUSE IS THAT DAMAGED OCCURRED AFTER THE PRODUCT LEFT THE MANUFACTURING FACILITIES. NO CORRECTIVE ACTIONS TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLANGE BROKE LEADING TO A TRACH CHANGE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552685 SILICONE - BIVONA TUBES NEO/PED TRACHEOSTOMY TUBE AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 60SP035 4056629 15021312000375

    Patients

    Seq Age Sex Outcome Treatment
    1 Male