BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FLEXICLEAR REG CAPACITY

    MDR report key: 2491671 · Received March 14, 2012

    Report

    Report Number
    1423537-2012-00011
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    February 10, 2012
    Report Date
    March 14, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS NOT RETURNED FOR INVESTIGATION. UNFORTUNATELY, WITHOUT THE INVOLVED SAMPLE, WE CANNOT CONFIRM THE ISSUE REPORTED. THE DEVICE HISTORY RECORD FOR BATCH REPORTED 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. IN ADDITION, THE SUB-ASSEMBLY PART NUMBER 65-4038 WAS REVIEWED AND NO ISSUES WERE OBSERVED FOR BATCH (B)(4) (MANUFACTURED IN AUGUST 2011) AND BATCH (B)(4) (MANUFACTURED IN SEPTEMBER 2011) AT OUR CARE FUSION SUPPLIER. AT THIS MOMENT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE. NO CORRECTIVE ACTION WILL BE IMPLEMENTED AT THIS TIME SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION. BASED ON OUR INVESTIGATION IS NOT POSSIBLE TO DETERMINE A CORRECTIVE ACTION.

    Description of Event or Problem · 1

    TH HOSPITAL EXPERIENCED AN INCIDENT WHERE A PATIENT HAD A SUCTION TIP THAT WAS CRUSHED IN THEIR MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDLE FLEXICLEAR REG CAPACITY SUCTION HANDLE JOL CARDINAL HEALTH K61 000356660

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention