BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUBATION ACCESSORIES

    MDR report key: 15398012 · Received September 11, 2022

    Report

    Report Number
    3012307300-2022-18601
    Event Type
    Malfunction
    Date Received
    September 11, 2022
    Date of Event
    August 1, 2020
    Report Date
    September 11, 2022
    Manufacturer
    NULL
    Product Code
    NXA
    PMA / PMN Number
    K844051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: 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. THE RETURNED SAMPLE WAS FOUND REJECTED, SINCE THE EDGE OF THE PRODUCT DID NOT REACH THE LIMITS AFTER APPLYING 3.5 KG FORCE. COMPLAINT IS CONFIRMED SINCE RETURNED SAMPLES WERE FOUND DEFECTIVE SINCE THE EDGE OF THE COMPONENT DID NOT REACH THE LIMITS FOR LUER TAPE TEST. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE RELATED TO A SUPPLIER ISSUE SINCE THE DEFECTIVE COMPONENT. G2 IS UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER ATTEMPTED TO CONNECT THE PRODUCT TO A TRACHEOSTOMY TUBE AT A PRE-USE CHECK, BUT COULD NOT DO IT SUCCESSFULLY BECAUSE THE CONNECTOR DID NOT FIT THE MATING ONE IN SIZE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306420 INTUBATION ACCESSORIES TRACHEOTOMY CARE KI NXA 3887696

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown