BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    READY CARE TIP

    MDR report key: 1348792 · Received February 5, 2009

    Report

    Report Number
    8030647-2009-00004
    Event Type
    Malfunction
    Date Received
    February 5, 2009
    Date of Event
    December 26, 2008
    Report Date
    January 26, 2009
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WILL BE PROVIDED FOR ADDITIONAL EVAL. HOWEVER, THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WAS REVIEWED FINDING NO ANOMALIES TO BE DOCUMENTED. ACCORDING TO THIS PRODUCT CODE'S PULL TEST SPECIFICATION LIMITS, THE SUBJECT LOT MET THE BOND STRENGTH SPECIFICATIONS OF 20LBS. TO IMPROVE THIS PROCESS, THE BONDING MACHINERY HAS BEEN REPLACED WHICH HAS INCREASED THE PULL TEST RESULTS OF SUBSEQUENT LOTS TO 40LBS. WITHIN THE LAST 2 YEARS, THIS IS 1 OF 2 COMPLAINTS RECEIVED FOR THIS PRODUCT CODE AND THE SUBJECT INCIDENT. WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATIONS WILL BE INITIATED AND CORRECTIVE ACTION TAKEN IF INDICATED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE USER FACILITY THAT THE READY CARE TIP ALLEGEDLY CAME APART FROM THE READY CARE ORAL SUCTION PROBE. THE TIP ALLEGEDLY ENTERED THE PT'S AIRWAY AND WAS LATER COUGHED UP. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH AS A RESULT OF THE PRODUCT PROBLEM. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFO THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 READY CARE TIP ORAL CARE MOUTH SWABS KXF AVENT S. DE R.L. DE C.V. 410419/M81330701

    Patients

    Seq Age Sex Outcome Treatment
    1