BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YANK SUCT HNDL ONLY 50/CS

    MDR report key: 4916656 · Received July 15, 2015

    Report

    Report Number
    1423537-2015-00049
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 12, 2015
    Report Date
    July 15, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED AND FORWARDED ON TO THE MANUFACTURING FACILITY FOR INVESTIGATION. A SAMPLE WAS NOT AVAILABLE FOR COMPLAINT ANALYSIS; HOWEVER, A PICTURE WAS PROVIDED AND THE BROKEN AREA WAS CONFIRMED. THE DEVICE HISTORY RECORD FOR BATCH REPORTED 0000659495 (MANUFACTURED IN APRIL 2014) WAS REVIEWED. THIS INVESTIGATION DETERMINED THAT ALL PRODUCTS WERE MANUFACTURED, INSPECTED, AND RELEASED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND NO ISSUES WERE FOUND RELATED TO THE REPORTED ISSUE. WITHOUT THE SAMPLE, WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE SAMPLE IS PROVIDED AT A LATER DATE, THE INVESTIGATION WILL BE RE-OPENED AND A FOLLOW-UP REPORT FILED.

    Description of Event or Problem · 1

    DURING SURGERY, TWO PIECES BROKE OFF FROM THE TIP OF THE SUCTION HANDLE. THE LARGER PIECE WAS LOCATED NEAR THE SUCTION AND REMOVED. THE SMALLER PART WAS NOT LOCATED AND PROBABLY WAS SUCKED OFF INTO THE GEL OF THE SUCTION CANISTER. AFTER SURGERY, THE PATIENT WAS INFORMED ABOUT THE INCIDENT. THE PROCEDURE WAS NOT DELAYED AND ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO SIGNS OF INFECTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461095 YANK SUCT HNDL ONLY 50/CS SUCTION HANDLE JOL CARDINAL HEALTH KEX80 0000659495

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other