BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 857831 · Received June 1, 2007

    Report

    Report Number
    9611451-2007-00188
    Event Type
    Malfunction
    Date Received
    June 1, 2007
    Report Date
    May 3, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT DEVICE NOT RETURNED YET - LOT NUMBER PROVIDED: 070213. AN INITIAL INVESTIGATION HAS BEEN DONE BASED ON THE EVENT DESCRIPTION AND PREVIOUS INVESTIGATIONS. RESULTS: OUR RECORDS INDICATE THAT THIS IS THE ONLY SUCH COMPLAINT RECEIVED FOR THE GIVEN LOT NUMBER TO DATE. THE RT021 SUCTION PORT SEALS ARE SUPPLIED TO FISHER AND PAYKEL HEALTHCARE. OUR SUPPLIER HAS BEEN NOTIFIED OF THE FAULT, AND FURTHER TRAINING HAS BEEN PROVIDED TO OUR MANUFACTURING PERSONNEL ON INSPECTION OF THE SPLIT IN THE SEAL. THE LOT DATE ON THIS COMPLAINT SHOWS THAT THE PRODUCT WAS MANUFACTURED BEFORE NOTIFICATION TO THE SUPPLIER AND BEFORE TRAINING TOOK EFFECT. CONCLUSIONS: THIS IS A KNOWN PROBLEM AND IS DUE TO A MANUFACTURING ERROR. WE WILL BE FOLLOWING UP WITH OUR SUPPLIER ON THIS ISSUE. THE OCCURRENCE RATE FOR SUCH COMPLAINTS IS LESS THAN 0.024% WORLDWIDE FOR THE LAST YEAR. WE WILL CONTINUE TO TREND AND MONITOR ALL COMPLAINTS FOR THIS FAULT.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY REPORTED TO US THAT THERE WERE NO SLITS AT THE AUCTION PORT END OF THE RT021 CATHETER MOUNT - LOT NO. 070213. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER MOUNT BZO FISHER & PAYKEL HEALTHCARE, LTD. RT021 070213

    Patients

    Seq Age Sex Outcome Treatment
    1 YR