BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL CARE KIT,W/MOIST,PEROXIDE

    MDR report key: 6322094 · Received February 10, 2017

    Report

    Report Number
    8030647-2017-00026
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    January 17, 2017
    Report Date
    March 14, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED AND EVALUATED. ONE SAMPLE WAS RECEIVED WITH THE PACKAGE LABEL. THE SAMPLE WAS RECEIVED INSIDE A BIO-HAZARD SAMPLE BAG. THE SAMPLE WAS DISINFECTED INSIDE THE LAB HOOD USING CAVIWIPES. THE SWAB APPEARS IN CLEAN CONDITION WITH NO OBVIOUS VISIBLE SIGNS OF USE. THE SWAB STICK WAS BROKEN AT APPROXIMATELY 3.25" FROM THE END. UNDER MAGNIFICATION, STRESS WHITENING WAS OBSERVED ON THE BROKEN ENDS. LATERAL WHITE STRIATIONS WERE ALSO OBSERVED ADJACENT TO THE BREAK. THE SWAB SPONGE WAS SECURELY ATTACHED TO THE STICK. ROOT HAS NOT BEEN DETERMINED AND THE INVESTIGATION IS ONGOING. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, M6228A601, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED(B)(4).

    Additional Manufacturer Narrative · 1

    PRO CODE: -KXF, MFG SITE FOR DEVICES: (B)(4). ALL INFORMATION REASONABLY KNOWN AS OF 31MAR2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ORAL SWAB BROKE WHILE IN USE WITH A PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 24-JAN-2017 THAT STATES, "WHILE USING AN ORAL SWAB, THE STICK BROKE. IT SNAPPED IN HALF WITH LITTLE PRESSURE BEING APPLIED." ADDITIONAL INFORMATION WAS RECEIVED ON 31-JAN-2017 THAT STATES, THE TWO ISSUES REPORTED ON (B)(6) 2017 ARE THE SAME INCIDENT AND ONLY ONE SHOULD BE REPORTED FOR (B)(6) 2017. THE ADDITIONAL EMAIL WAS PROVIDED TO GIVE MORE DETAILED INFORMATION AND THERE WAS ONLY ONE PATIENT INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104218 ORAL CARE KIT,W/MOIST,PEROXIDE VAP ORAL CARE PRODUCTS KXF HALYARD HEALTH 12260 M6228A601

    Patients

    Seq Age Sex Outcome Treatment
    1