BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL SILICONE BIVONA ADULT TRACHEOSTOMY TUBE

    MDR report key: 9327672 · Received November 15, 2019

    Report

    Report Number
    3012307300-2019-05898
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Report Date
    October 25, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS NUMBER (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. A VISUAL INSPECTION FOUND THE KEYPAD AND LABELS INTACT. THE PUMP WAS IN GOOD PHYSICAL CONDITION. A REVIEW OF THE EVENT HISTORY LOG FOUND NO EVIDENCE OF THE REPORTED PROBLEM IN THE HISTORY. FUNCTIONAL TESTING CONFIRMED THE REPORTED EVENT. DURING TESTING, THE PUMP FAILED THE SYRINGE SENSOR TEST. THE ROOT CAUSE OF THE PROBLEM WAS A DAMAGED SYRINGE SENSOR. THE SYRINGE SENSOR (SENSOR IS PART OF THE REAR HOUSING) AND REAR HOUSING WERE REPLACED TO RESOLVE THE PROBLEM.

    Additional Manufacturer Narrative · 1

    POTENTIAL LOTS INCLUDE: 3782520, 3831778, 3831779, 377445, 3782520. EIGHT TRACHEOSTOMY TUBES WERE RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE EIGHT CUFFS FOUND TINY SCRATCHES NEXT TO THE SMALL HOLES ON THE CUFFS, PERHAPS CAUSED BY THE DEVICE COMING INTO CONTACT WITH SOMETHING SHARP EXTERNALLY OR POTENTIALLY FROM HARD CARTILAGE INTERNAL TO THE PATIENT. THE DEVICES THEN UNDERWENT FUNCTIONAL TESTING; CUFFS WERE LEAK TESTED. CUFFS WERE UNABLE TO FULLY INFLATE, IMMEDIATELY DEFLATING AS AIR ESCAPED FROM A SMALL HOLE. THE HOLES AND SCRATCHES ALIGN IN THE SAME LOCATIONS ON THE CUFFS WITH ALL EIGHT SAMPLES. THIS INVESTIGATION HAS CONFIRMED THE REPORTED CUSTOMER COMPLAINT. WHILE NO DEFINITIVE PROBLEM SOURCE TO THE REPORTED ISSUE COULD BE DETERMINED, THIS INVESTIGATION REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A CAUSE OF ISSUE RELATED TO MANUFACTURING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE, THE CUFF WAS NOTED TO HAVE A PINHOLE LEAK. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124041 SMITHS MEDICAL SILICONE BIVONA ADULT TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female