BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE ADULT CIRCUIT TUBING

    MDR report key: 2809221 · Received October 30, 2012

    Report

    Report Number
    9611451-2012-00777
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Report Date
    October 3, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE OF THE COMPLAINT TUBES WAS RECEIVED FOR EVALUATION. THE TUBE WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: VISUAL INSPECTION OF THE COMPLAINT TUBE REVEALED TEARS IN THE OUTER FILM OF THE TUBING. THE TUBING APPEARED TO BE DELAMINATING IN SOME PLACES. THIS WAS THE SECOND COMPLAINT RECEIVED FOR THE 900MR068 TUBING, FOR LOT 111020. CONCLUSION: BASED ON THE FACT THAT THE DAMAGE WAS FOUND PRIOR TO USE, WE HAVE DETERMINED THAT THE DAMAGE WAS THE RESULT OF A MANUFACTURING FAULT THAT WAS NOT PICKED DURING THE VENDOR'S INSPECTION OR WHILE BEING PACKED AT FISHER & PAYKEL HEALTHCARE'S PRODUCTION FACILITY. THE REUSABLE TUBING IS MANUFACTURED BY SMOOTH-BOR PLASTICS IN CALIFORNIA. SAMPLES OF THE COMPLAINT TUBES WERE SENT TO SMOOTH-BOR FOR EVALUATION. SMOOTH-BOR EVALUATED AND TESTED THE DEVICES AND REPORTED THAT THEY COULD NOT IDENTIFY A FAILURE MODE, AS THE TUBES WHEN RECEIVED WERE RUN AT ALMOST NOMINAL FOR ALL PARAMETERS REVIEWED. THEY FURTHER STATED THAT THE MATERIAL USED FOR THE 900MR068 TUBING IS THE MOST STURDY MATERIAL THAT THEY OFFER. WHEN ASKED ABOUT QUALITY CHECKS, THEY TOLD US THAT A PULL TEST IS DONE ON THE LINE BY GRASPING THE TUBE WITH THE HANDS ABOUT HALF A METER APART AND PULLING EVENLY IN OPPOSITE DIRECTIONS. IF THERE IS AN ADHESION//INTERFACE PROBLEM THE TUBE WILL BREAK ALMOST IMMEDIATELY. THEY ASSURED US THAT THIS IS HOW ADHESION/INTERFACE INTEGRITY HAS BEEN CHECKED FOR (B)(4) YEARS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT FIVE 900MR068 REUSABLE ADULT CIRCUIT TUBES HAD HOLES IN THEM. FOUR FAILED THE PRE-USE VENTILATOR LEAK TEST AND ONE FAILED WHILE IN USE ON A PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE ADULT CIRCUIT TUBING BZO BZO FISHER & PAYKEL HEALTHCARE LTD 900MR068 111020

    Patients

    Seq Age Sex Outcome Treatment
    1