BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED LLC

    MDR report key: 14104844 · Received April 13, 2022

    Report

    Report Number
    1314417-2022-00014
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 17, 2022
    Report Date
    April 13, 2022
    Manufacturer
    SUNMED LLC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE OF DEVICE WOULD DELAYED INTUBATION OF THE PATIENT. BASED ON THE REPORTED INFORMATION AND THE EVENT ORIGINATING IN THE US, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Additional Manufacturer Narrative · 0

    FAILURE OF DEVICE WOULD DELAYED INTUBATION OF THE PATIENT. BASED ON THE REPORTED INFORMATION AND THE EVENT ORIGINATING IN THE US, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET. COMPLAINT HISTORY REVIEWED. THERE HAVE BEEN 2 PREVIOUS COMPLAINTS FOR THIS ISSUE IN THE PREVIOUS 24 MONTHS. NCMR-02423 WAS ISSUED TO CONDUCT 100% SORT TO CONFIRM COMPLAINT. DEFECT WAS FOUND TO HAVE A RATE OF 1/4360. SUPPLIER INVESTIGATION INTO COMPLAINT DID NOT FIND ROOT CAUSE(SEE CC-07170) HOWEVER SUPPLIER HAS REQUESTED A CHANGE IN RESIN TO REDUCE THE OCCURRENCE OF THIS ISSUE. RISK (RMA-20002B): R5: PLASTIC HEEL BREAKING - TORSION OR TENSILE FORCES - S=7, O=2, RPN=14. RPN < 25, THEREFORE RISK IS ACCEPTABLE.

    Description of Event or Problem · 0

    THE HANDLE BROKE IN THE PATIENT'S MOUTH.

    Description of Event or Problem · 0

    THE HANDLE BROKE IN THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131874 SUNMED LLC GREENLINE D F/O LED LARGE HANDLE CCW SUNMED LLC 5-0236-69

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other